Trial Outcomes & Findings for A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy (NCT NCT03652064)
NCT ID: NCT03652064
Last Updated: 2026-04-08
Results Overview
Overall MRD negativity rate was defined as the percentage of participants who achieved complete response (CR) or better response and had MRD negative status (at 10\^5) by bone marrow biopsy or aspirate after randomization but prior to progressive disease (PD), subsequent anti-myeloma therapy, or both. CR or better rate was defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent anti-myeloma therapy in accordance with the International Myeloma Working Group (IMWG) criteria during or after the study treatment. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (\<) 5 percent (%) plasma cells (PCs) in bone marrow. sCR was defined as CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
395 participants
Primary outcome timeframe
From randomization (Day 1) up to 27.9 months
Results posted on
2026-04-08
Participant Flow
Participant milestones
| Measure |
Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
197
|
|
Overall Study
Treated
|
195
|
197
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
198
|
197
|
Reasons for withdrawal
| Measure |
Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
|---|---|---|
|
Overall Study
Death
|
54
|
50
|
|
Overall Study
Withdrawal by Subject
|
13
|
11
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Randomized but not treated
|
3
|
0
|
|
Overall Study
Ongoing
|
126
|
135
|
Baseline Characteristics
A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
Baseline characteristics by cohort
| Measure |
Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
n=198 Participants
Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
n=197 Participants
Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
Total
n=395 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Not reported
|
16 Participants
n=527 Participants
|
13 Participants
n=527 Participants
|
29 Participants
n=1054 Participants
|
|
Age, Continuous
|
70.0 years
n=527 Participants
|
70.0 years
n=527 Participants
|
70 years
n=1054 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=527 Participants
|
110 Participants
n=527 Participants
|
197 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=527 Participants
|
87 Participants
n=527 Participants
|
198 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=527 Participants
|
31 Participants
n=527 Participants
|
66 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
147 Participants
n=527 Participants
|
154 Participants
n=527 Participants
|
301 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=527 Participants
|
12 Participants
n=527 Participants
|
28 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
White
|
156 Participants
n=527 Participants
|
162 Participants
n=527 Participants
|
318 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=527 Participants
|
10 Participants
n=527 Participants
|
19 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=527 Participants
|
11 Participants
n=527 Participants
|
25 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
1 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=527 Participants
|
1 Participants
n=527 Participants
|
3 Participants
n=1054 Participants
|
PRIMARY outcome
Timeframe: From randomization (Day 1) up to 27.9 monthsPopulation: The intent-to-treat (ITT) analysis set included all participants who had been randomly assigned to the D-VRd or VRd group.
Overall MRD negativity rate was defined as the percentage of participants who achieved complete response (CR) or better response and had MRD negative status (at 10\^5) by bone marrow biopsy or aspirate after randomization but prior to progressive disease (PD), subsequent anti-myeloma therapy, or both. CR or better rate was defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent anti-myeloma therapy in accordance with the International Myeloma Working Group (IMWG) criteria during or after the study treatment. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (\<) 5 percent (%) plasma cells (PCs) in bone marrow. sCR was defined as CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Outcome measures
| Measure |
Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
n=198 Participants
Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
n=197 Participants
Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
|---|---|---|
|
Primary Analysis: Overall Minimal Residual Disease (MRD) Negative Rate
|
35.4 Percentage of participants
Interval 28.7 to 42.4
|
53.3 Percentage of participants
Interval 46.1 to 60.4
|
PRIMARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsPopulation: The intent-to-treat (ITT) analysis set included all participants who had been randomly assigned to the D-VRd or VRd group.
Overall MRD negativity rate was defined as the percentage of participants who achieved CR or better response and had MRD negative status (at 10\^5) by bone marrow biopsy or aspirate after randomization but prior to PD, subsequent anti-myeloma therapy, or both. CR or better rate was defined as the percentage of participants achieving CR or sCR prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria during or after the study treatment. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and \< 5 % PCs in bone marrow. sCR was defined as CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Outcome measures
| Measure |
Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
n=198 Participants
Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
n=197 Participants
Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
|---|---|---|
|
Final Progression-Free Survival (PFS) Analysis : Overall Minimal Residual Disease (MRD) Negative Rate
|
39.4 Percentage of participants
Interval 32.5 to 46.6
|
60.9 Percentage of participants
Interval 53.7 to 67.8
|
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 YearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening (-28 Days) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 and post dose on Day 4 of Cycles 1, 3 (each cycle consisted of 21 days); Predose on Day 1 of Cycles 9 and 12 (each cycle consisted of 28 days); Post treatment Week 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 and post dose on Day 4 of Cycles 1 and 3 (each cycle consisted of 21 days); Predose on Day 1 of Cycles 9 and 12 (each cycle consisted of 28 days); Post treatment Week 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 of Cycles 1, 9, and 12 (Cycle 1 consisted of 21 days, Cycles 9 and 12 consisted of 28 days); and Post-Treatment Week 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 of Cycles 1, 9, and 12 (Cycle 1 consisted of 21 days, Cycles 9 and 12 consisted of 28 days); and Post-Treatment Week 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening (-28 Days) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening (-28 Days) up to 64.8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening (-28 Days) up to 64.8 monthsOutcome measures
Outcome data not reported
Adverse Events
Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
Serious events: 131 serious events
Other events: 191 other events
Deaths: 59 deaths
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
Serious events: 142 serious events
Other events: 196 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
n=195 participants at risk
Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
n=197 participants at risk
Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
3.0%
6/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.0%
4/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.0%
4/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Arrhythmia Supraventricular
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Atrial Fibrillation
|
3.6%
7/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
3.6%
7/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Bradycardia
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Cardiac Arrest
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Cardiac Failure
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Cardiogenic Shock
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Myocardial Infarction
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Paroxysmal Arrhythmia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Sinus Bradycardia
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Eye disorders
Cataract
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.5%
5/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Eye disorders
Eye Inflammation
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Anal Fissure
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Colitis
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
6/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.1%
10/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Diverticulum Intestinal Haemorrhagic
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Enteritis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Femoral Hernia Incarcerated
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Gastrointestinal Wall Thickening
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Haematemesis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Mesenteric Arterial Occlusion
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Obstructive Pancreatitis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Asthenia
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
3.0%
6/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Chest Pain
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Death
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
General Physical Health Deterioration
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Hernia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Impaired Self-Care
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Influenza Like Illness
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Malaise
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Oedema Peripheral
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Pyrexia
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.5%
5/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Sudden Death
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Hepatobiliary disorders
Cholecystitis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Hepatobiliary disorders
Hepatic Failure
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Immune system disorders
Amyloidosis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Immune system disorders
Drug Hypersensitivity
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Abscess Jaw
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Acute Sinusitis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Bronchitis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Candida Infection
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Cellulitis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Coronavirus Infection
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Covid-19
|
8.2%
16/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
11.2%
22/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Covid-19 Pneumonia
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
4.1%
8/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Cystitis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Cytomegalovirus Infection Reactivation
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Device Related Sepsis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Diarrhoea Infectious
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Diverticulitis
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Gastroenteritis
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.0%
4/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Genital Herpes
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Groin Infection
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Herpes Zoster
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Infected Skin Ulcer
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Infection
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Influenza
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.0%
4/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Large Intestine Infection
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Neutropenic Sepsis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Osteomyelitis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pancreatic Abscess
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Periorbital Cellulitis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Peritonitis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pneumonia
|
12.8%
25/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
13.7%
27/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pneumonia Bacterial
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pneumonia Cryptococcal
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pneumonia Influenzal
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pneumonia Legionella
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Postoperative Wound Infection
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Prostatic Abscess
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pulmonary Sepsis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pyuria
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Respiratory Tract Infection
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Respiratory Tract Infection Bacterial
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Sepsis
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
3.6%
7/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Septic Shock
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
3.0%
6/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Skin Infection
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Staphylococcal Infection
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Tuberculosis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Urinary Tract Infection
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
3.6%
7/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Urosepsis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Acetabulum Fracture
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Concussion
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Investigations
Blood Creatinine Increased
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Investigations
Troponin I Increased
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
5/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.5%
5/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.5%
5/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Mineral Deficiency
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Tetany
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Fracture Pain
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Compression
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Muscle Atrophy
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of Jaw
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of Colon
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Thyroid Gland
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear Cell Renal Cell Carcinoma
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Tract Adenoma
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma Stage Ii
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma Stage Iii
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Squamous Cell Carcinoma
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Adenocarcinoma
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenoma
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of the Oral Cavity
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Brain Stem Infarction
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Dizziness
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Encephalopathy
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Facial Paralysis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Headache
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Optic Neuritis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Paraparesis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Presyncope
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Radiculopathy
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Sciatica
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Seizure
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Syncope
|
3.1%
6/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Apathy
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Completed Suicide
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Confusional State
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Depression
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Depressive Delusion
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Substance-Induced Psychotic Disorder
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
3.0%
6/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Renal and urinary disorders
Nephropathy
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Renal and urinary disorders
Oliguria
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Renal and urinary disorders
Renal Failure
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Reproductive system and breast disorders
Prostatic Obstruction
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.6%
5/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.6%
11/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Sjs-Ten Overlap
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Toxic Skin Eruption
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Arterial Thrombosis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.0%
4/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Embolism
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Haematoma
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Hypertension
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Hypotension
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.5%
3/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Hypovolaemic Shock
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Orthostatic Hypotension
|
2.6%
5/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
1.0%
2/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Thrombosis
|
0.00%
0/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.51%
1/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Venous Thrombosis
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
0.00%
0/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
Other adverse events
| Measure |
Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
n=195 participants at risk
Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
n=197 participants at risk
Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.8%
62/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
36.0%
71/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.7%
19/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
14.2%
28/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Blood and lymphatic system disorders
Lymphopenia
|
17.4%
34/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
18.3%
36/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Blood and lymphatic system disorders
Neutropenia
|
39.0%
76/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
54.8%
108/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.8%
66/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
46.2%
91/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Cardiac disorders
Atrial Fibrillation
|
8.7%
17/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.1%
12/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Ear and labyrinth disorders
Tinnitus
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.1%
12/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
13/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
8.1%
16/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Eye disorders
Cataract
|
25.6%
50/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
26.9%
53/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Eye disorders
Dry Eye
|
8.7%
17/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
4.6%
9/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Eye disorders
Vision Blurred
|
9.7%
19/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
12.2%
24/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.7%
15/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
4.1%
8/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.7%
19/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
15.2%
30/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.7%
13/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
9.1%
18/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Constipation
|
42.1%
82/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
38.1%
75/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Diarrhoea
|
57.4%
112/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
56.3%
111/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Dry Mouth
|
6.7%
13/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
3.0%
6/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Dyspepsia
|
8.7%
17/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
13.2%
26/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.1%
6/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.1%
12/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Nausea
|
24.1%
47/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
24.9%
49/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Stomatitis
|
5.1%
10/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
7.1%
14/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Toothache
|
5.1%
10/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.6%
11/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
23/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
11.7%
23/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Asthenia
|
19.5%
38/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
25.4%
50/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Chills
|
1.0%
2/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
7.1%
14/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Fatigue
|
30.8%
60/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
32.0%
63/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Influenza Like Illness
|
10.3%
20/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
12.2%
24/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Injection Site Erythema
|
5.1%
10/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
12.7%
25/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Malaise
|
9.7%
19/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
4.6%
9/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Oedema Peripheral
|
39.0%
76/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
42.1%
83/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Peripheral Swelling
|
8.2%
16/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
9.1%
18/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
General disorders
Pyrexia
|
14.4%
28/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
21.8%
43/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.1%
10/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.5%
5/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Immune system disorders
Hypogammaglobulinaemia
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
8.1%
16/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Bronchitis
|
9.2%
18/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
14.2%
28/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Conjunctivitis
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
8.1%
16/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Covid-19
|
20.5%
40/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
29.9%
59/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Herpes Zoster
|
5.1%
10/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.1%
10/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Hordeolum
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.1%
10/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Influenza
|
7.2%
14/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
12.2%
24/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
22/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
17.8%
35/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pharyngitis
|
6.7%
13/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.6%
11/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Pneumonia
|
9.2%
18/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
14.7%
29/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Respiratory Tract Infection
|
3.1%
6/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.1%
10/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Rhinitis
|
3.6%
7/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.6%
13/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Sinusitis
|
2.6%
5/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
8.1%
16/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Tooth Infection
|
3.6%
7/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.6%
11/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
32.8%
64/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
39.1%
77/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Infections and infestations
Urinary Tract Infection
|
13.8%
27/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
19.3%
38/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Contusion
|
10.3%
20/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
12.2%
24/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
12/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
8.6%
17/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Investigations
Alanine Aminotransferase Increased
|
13.8%
27/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
13.2%
26/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.7%
17/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
8.1%
16/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
4.6%
9/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.6%
13/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Investigations
Blood Creatinine Increased
|
9.2%
18/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.6%
13/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Investigations
Weight Decreased
|
11.3%
22/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
7.6%
15/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
19.0%
37/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
21.3%
42/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
11/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
2.5%
5/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.7%
19/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
11.2%
22/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.2%
16/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
14.2%
28/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.8%
25/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
27.4%
54/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
12/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
8.1%
16/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.3%
20/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
7.1%
14/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.5%
3/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.6%
11/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
39/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
22.3%
44/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
22.1%
43/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
27.4%
54/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.2%
14/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
9.1%
18/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
15.4%
30/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
18.3%
36/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
14.4%
28/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
19.3%
38/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
7.2%
14/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
9.1%
18/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
10.8%
21/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
12.2%
24/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
12/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
7.1%
14/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.6%
9/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.6%
13/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
14.9%
29/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
16.8%
33/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
7.2%
14/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
7.1%
14/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Dizziness
|
21.0%
41/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
20.8%
41/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Dysgeusia
|
11.3%
22/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
9.6%
19/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Headache
|
7.7%
15/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
15.2%
30/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Hypoaesthesia
|
4.1%
8/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.6%
13/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Neuralgia
|
15.4%
30/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
14.2%
28/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Paraesthesia
|
9.2%
18/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
12.7%
25/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.6%
13/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Peripheral Sensorimotor Neuropathy
|
4.6%
9/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.1%
10/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
60.5%
118/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
55.8%
110/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Nervous system disorders
Tremor
|
7.7%
15/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
9.6%
19/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Anxiety
|
6.2%
12/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
7.6%
15/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Confusional State
|
6.2%
12/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.1%
10/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Depression
|
7.2%
14/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
9.1%
18/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Psychiatric disorders
Insomnia
|
32.3%
63/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
32.0%
63/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Renal and urinary disorders
Dysuria
|
2.1%
4/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
8.6%
17/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Renal and urinary disorders
Renal Failure
|
3.6%
7/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.1%
10/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Renal and urinary disorders
Renal Impairment
|
10.3%
20/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
7.1%
14/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.5%
38/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
26.9%
53/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.6%
9/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.1%
10/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.9%
29/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
17.3%
34/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.1%
10/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
3.6%
7/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.1%
8/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
9.6%
19/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
3.6%
7/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
8.6%
17/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.6%
7/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
7.6%
15/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.2%
14/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
8.6%
17/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
12/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.1%
12/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.3%
22/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
10.7%
21/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.6%
48/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
25.4%
50/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
9.2%
18/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.6%
13/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
4.6%
9/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
5.1%
10/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Deep Vein Thrombosis
|
8.7%
17/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
7.1%
14/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Haematoma
|
0.51%
1/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
6.1%
12/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Hypertension
|
7.2%
14/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
17.8%
35/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
|
Vascular disorders
Hypotension
|
10.8%
21/195 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
14.7%
29/197 • Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set included all participants who were randomized in the study .
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Study site and investigator shall not publish study results except as required by law or as specified in a separate, written agreement between the sponsor and the study site or investigator.
- Publication restrictions are in place
Restriction type: OTHER