Trial Outcomes & Findings for Platform Trial Evaluating Safety and Efficacy of Ezabenlimab Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours (NCT NCT03697304)
NCT ID: NCT03697304
Last Updated: 2026-01-27
Results Overview
Confirmed objective response (OR), defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
211 participants
Primary outcome timeframe
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
Results posted on
2026-01-27
Participant Flow
Platform trial evaluating the safety and efficacy of different ezabenlimab (BI 754091) treatment regimens on patients with different types of advanced or metastatic tumors: module C evaluated the efficacy and safety of ezabenlimab (BI 754091) in combination with BI 836880 and module A evaluated the efficacy and safety of ezabenlimab (BI 754091) in combination with BI 754111.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
28
|
30
|
18
|
2
|
33
|
42
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
30
|
28
|
30
|
18
|
2
|
33
|
42
|
Reasons for withdrawal
| Measure |
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other than listed
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Death
|
1
|
2
|
4
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Consent withdrawal
|
1
|
2
|
0
|
4
|
4
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
4
|
4
|
2
|
4
|
4
|
1
|
5
|
3
|
|
Overall Study
Progressive disease
|
21
|
20
|
22
|
22
|
8
|
1
|
25
|
37
|
Baseline Characteristics
Platform Trial Evaluating Safety and Efficacy of Ezabenlimab Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours
Baseline characteristics by cohort
| Measure |
Module C, Cohort 1: GEC Patients
n=28 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=30 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=28 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
n=30 Participants
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
n=18 Participants
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 1: GEC Patients
n=2 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 2: 2ary Resistance Patients
n=33 Participants
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 3: 1ary Resistance Patients
n=42 Participants
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.5 Years
STANDARD_DEVIATION 10.7 • n=41 Participants
|
63.2 Years
STANDARD_DEVIATION 13.3 • n=1581 Participants
|
60.6 Years
STANDARD_DEVIATION 10.9 • n=4626 Participants
|
57.7 Years
STANDARD_DEVIATION 13.5 • n=1267 Participants
|
67.8 Years
STANDARD_DEVIATION 11.3 • n=127 Participants
|
61.0 Years
STANDARD_DEVIATION 14.1 • n=19 Participants
|
68.6 Years
STANDARD_DEVIATION 7.2 • n=58 Participants
|
64.9 Years
STANDARD_DEVIATION 10.4 • n=2036 Participants
|
66.4 Years
STANDARD_DEVIATION 9.3 • n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
7 Participants
n=4626 Participants
|
13 Participants
n=1267 Participants
|
18 Participants
n=127 Participants
|
1 Participants
n=19 Participants
|
14 Participants
n=58 Participants
|
22 Participants
n=2036 Participants
|
93 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=41 Participants
|
20 Participants
n=1581 Participants
|
21 Participants
n=4626 Participants
|
17 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
1 Participants
n=19 Participants
|
19 Participants
n=58 Participants
|
20 Participants
n=2036 Participants
|
118 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
3 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
4 Participants
n=2036 Participants
|
10 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=41 Participants
|
16 Participants
n=1581 Participants
|
22 Participants
n=4626 Participants
|
27 Participants
n=1267 Participants
|
17 Participants
n=127 Participants
|
2 Participants
n=19 Participants
|
33 Participants
n=58 Participants
|
37 Participants
n=2036 Participants
|
162 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=41 Participants
|
12 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
1 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=2036 Participants
|
39 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=58 Participants
|
0 Participants
n=2036 Participants
|
2 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
2 Participants
n=1267 Participants
|
2 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=2036 Participants
|
10 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=1267 Participants
|
2 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
4 Participants
n=58 Participants
|
2 Participants
n=2036 Participants
|
10 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other
|
20 Participants
n=41 Participants
|
12 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
1 Participants
n=1267 Participants
|
1 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
3 Participants
n=2036 Participants
|
42 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=41 Participants
|
16 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
25 Participants
n=1267 Participants
|
13 Participants
n=127 Participants
|
2 Participants
n=19 Participants
|
28 Participants
n=58 Participants
|
36 Participants
n=2036 Participants
|
147 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.Population: Treated set of the module C: all patients treated with at least one dose of trial medications.
Confirmed objective response (OR), defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=28 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=30 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=28 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
n=30 Participants
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
n=18 Participants
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module C] Objective Response (OR)
|
14.3 percentage of participants
Interval 4.0 to 32.7
|
23.3 percentage of participants
Interval 9.9 to 42.3
|
0.0 percentage of participants
Interval 0.0 to 12.3
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
44.4 percentage of participants
Interval 21.5 to 69.2
|
PRIMARY outcome
Timeframe: From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.Population: Treated set of the module C: all patients treated with at least one dose of trial medications.
Confirmed objective response (OR), defined as the objective response rate (ORR) of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The estimated objective response rate is presented by the posterior medians of the Bayesian hierarchical model and by the correspondent credible intervals.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=28 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=30 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=28 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
n=30 Participants
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
n=18 Participants
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module C] Objective Response (OR) - Bayesian Hierarchical Model
|
NA percentage of participants
Posterior median = 11.95 97.5 % credible interval = (3.72, 25.31)
|
NA percentage of participants
Posterior median = 20.21 97.5 % credible interval = (9.61, 36.1)
|
NA percentage of participants
Posterior median = 2.75 97.5 % credible interval = (0.17, 10.15)
|
NA percentage of participants
Posterior median = 5.26 97.5 % credible interval = (0.83, 14.87)
|
NA percentage of participants
Posterior median = 36.13 97.5 % credible interval = (17.15, 59.63)
|
PRIMARY outcome
Timeframe: From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.Population: Treated set of the module A: all patients treated with at least one dose of trial medications.
Confirmed objective response (OR), defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=2 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=33 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=42 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module A] Objective Response (OR)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
6.1 percentage of participants
Interval 0.7 to 20.2
|
9.5 percentage of participants
Interval 2.7 to 22.6
|
—
|
—
|
PRIMARY outcome
Timeframe: From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.Population: Treated set of the module A: all patients treated with at least one dose of trial medications.
Confirmed objective response (OR), defined as the objective response rate (ORR) of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The estimated objective response rate is presented by the posterior medians of the Bayesian hierarchical model and by the correspondent credible intervals.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=2 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=33 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=42 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module A] Objective Response (OR) - Bayesian Hierarchical Model
|
NA percentage of participants
Posterior median = 9.69 97.5 % credible interval = (0.88, 35.04)
|
NA percentage of participants
Posterior median = 8.23 97.5 % credible interval = (2.12, 18.91)
|
NA percentage of participants
Posterior median = 6.67 97.5 % credible interval = (2.3, 16.02)
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death. Up to 174.6 weeks.Population: Treated set of the module C: all patients treated with at least one dose of trial medications. Only patients that had an unconfirmed OR were included in the analysis.
Duration of response (DoR) was defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) among patients with objective response (OR), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. DoR parameters were calculated based on Kaplan-Meier estimation. The analysis was performed on the unconfirmed OR.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=4 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=9 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=2 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
n=2 Participants
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
n=8 Participants
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module C] Duration of Response (DoR)
|
105.95 Weeks
Interval 12.3 to 174.6
|
30.90 Weeks
Interval 6.4 to 81.3
|
8.50 Weeks
Interval 8.4 to 8.6
|
25.00 Weeks
Interval 12.1 to 37.9
|
47.30 Weeks
Interval 6.1 to 143.1
|
SECONDARY outcome
Timeframe: From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.Population: Treated set of module C: all patients treated with at least one dose of trial medications.
Disease Control (DC) defined as the percentage of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=28 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=30 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=28 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
n=30 Participants
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
n=18 Participants
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module C] Disease Control (DC)
|
57.1 percentage of participants
Interval 37.2 to 75.5
|
73.3 percentage of participants
Interval 54.1 to 87.7
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
56.7 percentage of participants
Interval 37.4 to 74.5
|
77.8 percentage of participants
Interval 52.4 to 93.6
|
SECONDARY outcome
Timeframe: From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.Population: Treated set of module C: all patients treated with at least one dose of trial medications.
Disease Control (DC), defined as the disease control rate (DCR) of participants with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The estimated DCR is presented by the posterior medians of the bayesian hierarchical model and by the correspondent credible intervals.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=28 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=30 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=28 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
n=30 Participants
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
n=18 Participants
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module C] Disease Control (DC) - Bayesian Hierarchical Model
|
NA percentage of participants
Posterior median = 64.7 97.5% credible interval = (45.4, 77.8)
|
NA percentage of participants
Posterior median = 70.4 97.5% credible interval = (56.7, 83.8)
|
NA percentage of participants
Posterior median = 44.7 97.5% credible interval = (29.1, 59.8)
|
NA percentage of participants
Posterior median = 57.5 97.5% credible interval = (42.1, 71.5)
|
NA percentage of participants
Posterior median = 82.2 97.5% credible interval = (66.7, 96.1)
|
SECONDARY outcome
Timeframe: From first drug administration until PD or death, whichever occurred earlier. Up to approximately 186.1 weeks.Population: Treated set of module C: all patients treated with at least one dose of trial medications.
Progression-free survival (PFS) was defined as the time from first treatment administration until progressive disease (PD), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1), or death from any cause, whichever occurred earlier. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier estimation.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=28 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=30 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=28 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
n=30 Participants
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
n=18 Participants
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module C] Progression-free Survival (PFS)
|
13.4 Weeks
Interval 6.1 to 33.7
|
29.1 Weeks
Interval 13.0 to 48.7
|
6.1 Weeks
Interval 5.7 to 12.1
|
12.6 Weeks
Interval 6.1 to 23.6
|
75.0 Weeks
Interval 24.9 to
NA = not calculable due to insufficient number of participants with the event.
|
SECONDARY outcome
Timeframe: From first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death. Up to 63.6 weeks.Population: Treated set of the module A: all patients treated with at least one dose of trial medications. Only patients that had an unconfirmed OR were included in the analysis.
Duration of response (DoR) was defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) among patients with objective response (OR), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. DoR parameters were calculated based on Kaplan-Meier estimation. The analysis was performed on the unconfirmed OR.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=3 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=8 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module A] Duration of Response (DoR)
|
—
|
12.30 Weeks
Interval 5.7 to 31.4
|
28.30 Weeks
Interval 0.1 to 63.6
|
—
|
—
|
SECONDARY outcome
Timeframe: From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.Population: Treated set on module A: all patients treated with at least one dose of trial medications.
Disease Control (DC) defined as the percentage of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=2 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=33 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=42 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module A] Disease Control (DC)
|
0 percentage of participants
Interval 0.0 to 84.2
|
42.4 percentage of participants
Interval 25.5 to 60.8
|
45.2 percentage of participants
Interval 29.8 to 61.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.Population: Treated set on module A: all patients treated with at least one dose of trial medications.
Disease Control (DC), defined as the disease control rate (DCR) of participants with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The estimated DCR is presented by the posterior medians of the bayesian hierarchical model and by the correspondent credible intervals.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=2 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=33 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=42 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module A] Disease Control (DC) - Bayesian Hierarchical Model
|
NA percentage of participants
Posterior median = 10.83 97.5 % credible interval = (1.7, 28.79)
|
NA percentage of participants
Posterior median = 42.83 97.5 % credible interval = (28.86, 57.14)
|
NA percentage of participants
Posterior median = 44.18 97.5 % credible interval = (31.57, 57.68)
|
—
|
—
|
SECONDARY outcome
Timeframe: From first drug administration until PD, death, or cut-off date of July 2021, whichever occurred earlier. Up to approximately 104.7 weeks.Population: Treated set of module A: all patients treated with at least one dose of trial medications.
Progression-free survival (PFS) was defined as the time from first treatment administration until progressive disease (PD), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1), or death from any cause, whichever occurred earlier. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier estimation. Progression free survival was collected, according to the clinical trial protocol until July 2021.
Outcome measures
| Measure |
Module C, Cohort 1: GEC Patients
n=2 Participants
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=33 Participants
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=42 Participants
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|
|
[Module A] Progression-free Survival (PFS)
|
5.9 Weeks
Interval 5.7 to
NA = not evaluable due to insufficient number of participants with event
|
6.7 Weeks
Interval 5.9 to 11.9
|
8.9 Weeks
Interval 5.7 to 16.9
|
—
|
—
|
Adverse Events
Module C, Cohort 1: GEC Patients
Serious events: 11 serious events
Other events: 27 other events
Deaths: 24 deaths
Module C, Cohort 2: 2ary Resistance Patients
Serious events: 18 serious events
Other events: 27 other events
Deaths: 20 deaths
Module C, Cohort 3: 1ary Resistance Patients
Serious events: 12 serious events
Other events: 26 other events
Deaths: 22 deaths
Module C, Cohort 4: CRC Patients
Serious events: 13 serious events
Other events: 29 other events
Deaths: 17 deaths
Module C, Cohort 5: EC Patients
Serious events: 11 serious events
Other events: 18 other events
Deaths: 4 deaths
Module A, Cohort 1: GEC Patients
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Module A, Cohort 2: 2ary Resistance Patients
Serious events: 13 serious events
Other events: 33 other events
Deaths: 29 deaths
Module A, Cohort 3: 1ary Resistance Patients
Serious events: 12 serious events
Other events: 41 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Module C, Cohort 1: GEC Patients
n=28 participants at risk
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=30 participants at risk
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=28 participants at risk
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
n=30 participants at risk
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
n=18 participants at risk
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 1: GEC Patients
n=2 participants at risk
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 2: 2ary Resistance Patients
n=33 participants at risk
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 3: 1ary Resistance Patients
n=42 participants at risk
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
BANDAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
IMMUNE THROMBOCYTOPENIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
ACUTE LEFT VENTRICULAR FAILURE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
ATRIAL FIBRILLATION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
CARDIAC ARREST
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
MYOCARDITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
PERICARDIAL EFFUSION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
ENDOCRINE DISORDERS
ADRENAL INSUFFICIENCY
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
ASCITES
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
COLITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
ILEUS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
IMMUNE-MEDIATED ENTEROCOLITIS
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
LARGE INTESTINE PERFORATION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
OESOPHAGEAL OBSTRUCTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
OESOPHAGEAL PERFORATION
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
PANCREATITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
RECTAL HAEMORRHAGE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
DEATH
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
DEVICE RELATED THROMBOSIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FACE OEDEMA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
IMPLANT SITE PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
LOCALISED OEDEMA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MALAISE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
OEDEMA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
BILE DUCT STENOSIS
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
BILE DUCT STONE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
BILIARY OBSTRUCTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
DRUG-INDUCED LIVER INJURY
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
HEPATIC FAILURE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
HYPERBILIRUBINAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
HYPERTRANSAMINASAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
JAUNDICE CHOLESTATIC
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
LIVER INJURY
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
COVID-19
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
ENCEPHALITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
GASTROINTESTINAL INFECTION
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
INFECTED FISTULA
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
MENINGITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
PHARYNGITIS BACTERIAL
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
PNEUMONIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
PNEUMONIA ASPIRATION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
SEPSIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
SKIN INFECTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
VASCULAR DEVICE INFECTION
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FALL
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FEMUR FRACTURE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
HIP FRACTURE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
HUMERUS FRACTURE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
PROCEDURAL PNEUMOTHORAX
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
BLOOD CREATININE INCREASED
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
TROPONIN I INCREASED
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
DEHYDRATION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERCALCAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOKALAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPONATRAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
LACTIC ACIDOSIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
BASAL CELL CARCINOMA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
MYELODYSPLASTIC SYNDROME
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
TUMOUR ASSOCIATED FEVER
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
TUMOUR THROMBOSIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
CEREBROVASCULAR ACCIDENT
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
ENCEPHALOPATHY
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
SOMNOLENCE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
SYNCOPE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
PSYCHIATRIC DISORDERS
DELIRIUM
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
HAEMATURIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
HYDRONEPHROSIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
IMMUNE-MEDIATED NEPHRITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
NEPHRITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
URINARY RETENTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
URINARY TRACT OBSTRUCTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
PROSTATITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ACUTE RESPIRATORY FAILURE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ASPIRATION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ORGANISING PNEUMONIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSION
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PNEUMOTHORAX
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PULMONARY EMBOLISM
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RESPIRATORY FAILURE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DERMATITIS BULLOUS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
VASCULAR DISORDERS
DEEP VEIN THROMBOSIS
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
3/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
VASCULAR DISORDERS
HAEMORRHAGE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
VASCULAR DISORDERS
HYPERTENSION
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
Other adverse events
| Measure |
Module C, Cohort 1: GEC Patients
n=28 participants at risk
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
|
Module C, Cohort 2: 2ary Resistance Patients
n=30 participants at risk
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
|
Module C, Cohort 3: 1ary Resistance Patients
n=28 participants at risk
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 4: CRC Patients
n=30 participants at risk
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module C, Cohort 5: EC Patients
n=18 participants at risk
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 1: GEC Patients
n=2 participants at risk
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 2: 2ary Resistance Patients
n=33 participants at risk
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
Module A, Cohort 3: 1ary Resistance Patients
n=42 participants at risk
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
|
|---|---|---|---|---|---|---|---|---|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
14.3%
4/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
15.2%
5/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
14.3%
6/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
ATRIAL FIBRILLATION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
ATRIAL TACHYCARDIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
CARDIAC DISORDERS
TACHYCARDIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
EAR AND LABYRINTH DISORDERS
EAR DISCOMFORT
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
EAR AND LABYRINTH DISORDERS
EAR PAIN
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
EAR AND LABYRINTH DISORDERS
HYPOACUSIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
ENDOCRINE DISORDERS
HYPERTHYROIDISM
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
ENDOCRINE DISORDERS
HYPOTHYROIDISM
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
13.3%
4/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
20.0%
6/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
27.8%
5/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
7/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
EYE DISORDERS
CONJUNCTIVOCHALASIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
EYE DISORDERS
PERIORBITAL OEDEMA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
EYE DISORDERS
VISION BLURRED
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL DISTENSION
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
28.6%
8/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
13.3%
4/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
3/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.5%
4/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN UPPER
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
ASCITES
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
COLITIS
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
3/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
22.2%
4/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
18.2%
6/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
23.8%
10/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
32.1%
9/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
20.0%
6/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
17.9%
5/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
5/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
44.4%
8/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
21.2%
7/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.5%
4/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
DYSPEPSIA
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
DYSPHAGIA
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
3/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
EPIGASTRIC DISCOMFORT
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
FLATULENCE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
GINGIVAL BLEEDING
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
GINGIVAL PAIN
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
17.9%
5/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
23.3%
7/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
36.7%
11/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
38.9%
7/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
100.0%
2/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
36.4%
12/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
21.4%
9/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
ORAL DISCOMFORT
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
ORAL PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
PANCREATITIS ACUTE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
STOMATITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
TOOTHACHE
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
14.3%
4/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
20.0%
6/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
33.3%
10/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
38.9%
7/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
15.2%
5/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.9%
5/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ADMINISTRATION SITE REACTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHEST PAIN
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHILLS
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
12.1%
4/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
EARLY SATIETY
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FACE OEDEMA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
25.0%
7/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
26.7%
8/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
28.6%
8/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
36.7%
11/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
44.4%
8/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
36.4%
12/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
45.2%
19/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INFLUENZA LIKE ILLNESS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
NON-CARDIAC CHEST PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
OEDEMA PERIPHERAL
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
20.0%
6/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
14.3%
4/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
40.0%
12/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
33.3%
6/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.5%
4/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
3/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
12.1%
4/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.9%
5/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
SENSATION OF FOREIGN BODY
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
CHOLECYSTITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
HEPATOBILIARY DISORDERS
HYPERTRANSAMINASAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
COVID-19
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
22.2%
4/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
CYSTITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
FOLLICULITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
FUNGAL INFECTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
GASTROINTESTINAL VIRAL INFECTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
GROIN ABSCESS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
INFLUENZA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
LOWER RESPIRATORY TRACT INFECTION
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
ORAL HERPES
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
PNEUMONIA
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
12.1%
4/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
RHINITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
SINUSITIS
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
SKIN INFECTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
TOOTH ABSCESS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.9%
5/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
13.3%
4/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
27.8%
5/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
18.2%
6/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.9%
5/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
CORNEAL ABRASION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FALL
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
3/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
INFUSION RELATED REACTION
|
14.3%
4/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MUSCLE STRAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
ROAD TRAFFIC ACCIDENT
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
SPINAL COMPRESSION FRACTURE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
WOUND
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
ALANINE AMINOTRANSFERASE INCREASED
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
3/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
ASPARTATE AMINOTRANSFERASE INCREASED
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
13.3%
4/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
5/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
BLOOD BILIRUBIN INCREASED
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
BLOOD CREATININE INCREASED
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
13.3%
4/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
20.0%
6/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
BLOOD UREA INCREASED
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
PLATELET COUNT DECREASED
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
13.3%
4/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
RED BLOOD CELL COUNT INCREASED
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
VITAMIN D DECREASED
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
WEIGHT DECREASED
|
17.9%
5/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
14.3%
4/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
43.3%
13/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
3/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
21.2%
7/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
7/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
INVESTIGATIONS
WEIGHT INCREASED
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
5/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
5/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
27.8%
5/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
24.2%
8/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
21.4%
9/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
DEHYDRATION
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
3/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
21.2%
7/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.9%
5/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERCALCAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.5%
4/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERKALAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERLIPIDAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERURICAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
13.3%
4/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOALBUMINAEMIA
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOCALCAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
3/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOKALAEMIA
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
5/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOMAGNESAEMIA
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPONATRAEMIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
3/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
METABOLISM AND NUTRITION DISORDERS
VITAMIN B12 DEFICIENCY
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
|
17.9%
5/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
5/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
17.9%
5/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
24.2%
8/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.9%
5/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
SYNCOPE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
17.9%
5/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
14.3%
6/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
FLANK PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
12.1%
4/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
GROIN PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCLE SPASMS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
12.1%
4/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULAR WEAKNESS
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL CHEST PAIN
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MYALGIA
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
3/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
NECK PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
14.3%
4/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN EXTREMITY
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
22.2%
4/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
12.1%
4/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
3/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN JAW
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
APHASIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
DIZZINESS
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
3/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
18.2%
6/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.5%
4/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
DYSGEUSIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
HEADACHE
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
13.3%
4/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
22.2%
4/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
18.2%
6/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
3/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
MEMORY IMPAIRMENT
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
NEUROPATHY PERIPHERAL
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
PARALYSIS RECURRENT LARYNGEAL NERVE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
NERVOUS SYSTEM DISORDERS
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
PRODUCT ISSUES
DEVICE DISLOCATION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
PSYCHIATRIC DISORDERS
ANXIETY
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
PSYCHIATRIC DISORDERS
CONFUSIONAL STATE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
3/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
PSYCHIATRIC DISORDERS
DEPRESSION
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
PSYCHIATRIC DISORDERS
INSOMNIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
DYSURIA
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
HAEMATURIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
NEPHROLITHIASIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
NOCTURIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
POLLAKIURIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
PROTEINURIA
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
5/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RENAL AND URINARY DISORDERS
URINARY INCONTINENCE
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
COUGH
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
20.0%
6/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
27.8%
5/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
12.1%
4/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
23.8%
10/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPHONIA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
17.9%
5/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
18.2%
6/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.5%
4/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA EXERTIONAL
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
VASCULAR DISORDERS
HOT FLUSH
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
HAEMOTHORAX
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
LARYNGEAL PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
LOWER RESPIRATORY TRACT CONGESTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
NASAL CONGESTION
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
3/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
OROPHARYNGEAL PAIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSION
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.0%
3/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
50.0%
1/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
4.8%
2/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RHINITIS ALLERGIC
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RHINORRHOEA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
SINUS CONGESTION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DRY SKIN
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
HAND DERMATITIS
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PRURITUS
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
16.7%
5/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
3/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.7%
2/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH ERYTHEMATOUS
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
6.1%
2/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH MACULO-PAPULAR
|
7.1%
2/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.3%
1/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
9.1%
3/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
7.1%
3/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH PAPULAR
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH PRURITIC
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
5.6%
1/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
VASCULAR DISORDERS
HYPERTENSION
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
30.0%
9/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
21.4%
6/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
26.7%
8/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
38.9%
7/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.0%
1/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
2.4%
1/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
VASCULAR DISORDERS
HYPOTENSION
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
10.7%
3/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
18.2%
6/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
|
VASCULAR DISORDERS
LYMPHOEDEMA
|
0.00%
0/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
3.6%
1/28 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/30 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
11.1%
2/18 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/2 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/33 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
0.00%
0/42 • Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Treated set: all patients treated with at least one dose of trial medications.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER