Trial Outcomes & Findings for A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650) (NCT NCT02985957)
NCT ID: NCT02985957
Last Updated: 2025-12-22
Results Overview
Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
351 participants
Primary outcome timeframe
From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
Results posted on
2025-12-22
Participant Flow
Cohort A: Asymptomatic or minimally symptomatic, not previously received second generation hormone therapies or cytotoxic chemotherapy. Cohort B: Asymptomatic or minimally symptomatic, progressed after second generation hormone therapies and had not been treated with cytotoxic chemotherapy. Cohort C: Progressed after prior taxane-based cytotoxic chemotherapy. Cohort D: Progressed after prior docetaxel-containing therapy.
Participant milestones
| Measure |
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W
Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W
Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
|---|---|---|---|---|---|---|---|
|
Pre-Treatment Period
STARTED
|
2
|
45
|
45
|
73
|
74
|
38
|
74
|
|
Pre-Treatment Period
COMPLETED
|
2
|
45
|
45
|
73
|
73
|
38
|
72
|
|
Pre-Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Treatment Period
STARTED
|
2
|
45
|
45
|
73
|
73
|
38
|
72
|
|
Treatment Period
Eligible Participants Who Progressed and Received Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
|
0
|
0
|
0
|
0
|
0
|
13
|
27
|
|
Treatment Period
COMPLETED
|
0
|
0
|
0
|
5
|
3
|
19
|
25
|
|
Treatment Period
NOT COMPLETED
|
2
|
45
|
45
|
68
|
70
|
19
|
47
|
Reasons for withdrawal
| Measure |
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W
Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W
Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
|---|---|---|---|---|---|---|---|
|
Pre-Treatment Period
Participant no longer meets study criteria
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Pre-Treatment Period
Participant withdrew consent
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Pre-Treatment Period
Adverse event unrelated to study drug
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period
Participant withdrew consent
|
0
|
0
|
0
|
1
|
3
|
0
|
1
|
|
Treatment Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period
Other reasons
|
0
|
0
|
1
|
3
|
5
|
0
|
1
|
|
Treatment Period
Not reported
|
0
|
2
|
2
|
5
|
0
|
0
|
0
|
|
Treatment Period
Maximum clinical benefit
|
0
|
0
|
1
|
1
|
0
|
0
|
2
|
|
Treatment Period
Adverse event unrelated to study drug
|
1
|
4
|
1
|
2
|
8
|
2
|
7
|
|
Treatment Period
Study drug toxicity
|
1
|
23
|
20
|
12
|
20
|
3
|
5
|
|
Treatment Period
Disease progression
|
0
|
16
|
20
|
40
|
29
|
11
|
28
|
|
Treatment Period
Participant request to discontinue study treatment
|
0
|
0
|
0
|
4
|
2
|
2
|
3
|
|
Treatment Period
Poor/Non-Compliance
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
Baseline characteristics by cohort
| Measure |
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=2 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W
n=73 Participants
Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W
n=74 Participants
Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=74 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Total
n=351 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=18 Participants
|
15 Participants
n=102 Participants
|
21 Participants
n=30 Participants
|
25 Participants
n=37 Participants
|
23 Participants
n=127 Participants
|
16 Participants
n=77 Participants
|
23 Participants
n=37 Participants
|
124 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=18 Participants
|
30 Participants
n=102 Participants
|
24 Participants
n=30 Participants
|
48 Participants
n=37 Participants
|
51 Participants
n=127 Participants
|
22 Participants
n=77 Participants
|
51 Participants
n=37 Participants
|
227 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=18 Participants
|
45 Participants
n=102 Participants
|
45 Participants
n=30 Participants
|
73 Participants
n=37 Participants
|
74 Participants
n=127 Participants
|
38 Participants
n=77 Participants
|
74 Participants
n=37 Participants
|
351 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
1 Participants
n=77 Participants
|
1 Participants
n=37 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=18 Participants
|
40 Participants
n=102 Participants
|
40 Participants
n=30 Participants
|
53 Participants
n=37 Participants
|
56 Participants
n=127 Participants
|
28 Participants
n=77 Participants
|
51 Participants
n=37 Participants
|
270 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
5 Participants
n=102 Participants
|
5 Participants
n=30 Participants
|
19 Participants
n=37 Participants
|
18 Participants
n=127 Participants
|
9 Participants
n=77 Participants
|
22 Participants
n=37 Participants
|
78 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=18 Participants
|
33 Participants
n=102 Participants
|
37 Participants
n=30 Participants
|
70 Participants
n=37 Participants
|
72 Participants
n=127 Participants
|
32 Participants
n=77 Participants
|
67 Participants
n=37 Participants
|
313 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=18 Participants
|
6 Participants
n=102 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=37 Participants
|
2 Participants
n=127 Participants
|
5 Participants
n=77 Participants
|
6 Participants
n=37 Participants
|
24 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=18 Participants
|
5 Participants
n=102 Participants
|
5 Participants
n=30 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
1 Participants
n=77 Participants
|
1 Participants
n=37 Participants
|
13 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=18 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)Population: All treated Cohort B and C participants with measurable disease at baseline; pre-specified only to be collected for Cohorts B and C.
Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=32 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=30 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Cohorts B and C Per BICR
|
12.5 Percent of Participants
Interval 3.5 to 29.0
|
20.0 Percent of Participants
Interval 7.7 to 38.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)Population: All randomized Cohort D participants with measurable disease at baseline. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.
In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=46 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=23 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=45 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Cohort D
|
8.9 Percent of Participants
Interval 2.5 to 21.2
|
15.2 Percent of Participants
Interval 6.3 to 28.9
|
4.3 Percent of Participants
Interval 0.1 to 21.9
|
11.1 Percent of Participants
Interval 3.7 to 24.1
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)Population: All treated Cohort B and C participants. (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of first treatment. Pre-specified only to be collected for Cohorts B and C.
Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first. The following progressive diseases were collected, documented and assessed as below: Radiographic progression per retrospective Blinded Independent Central Review (BICR) assessment 1. Bone disease progression by Prostate Cancer Working Group (PCWG2) 2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR
|
7.59 Months
Interval 3.65 to 10.22
|
5.36 Months
Interval 2.92 to 7.66
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)Population: All randomized Cohort D participants (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.
Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first. The following progressive diseases were collected, documented and assessed as below: Radiographic progression per BICR assessment 1. Bone disease progression by (Prostate Cancer Working Group) PCWG2 2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=74 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=74 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Radiographic Progression-Free Survival (rPFS) for Cohort D
|
3.94 Months
Interval 2.17 to 7.62
|
4.17 Months
Interval 3.32 to 5.59
|
3.48 Months
Interval 2.14 to 5.78
|
7.92 Months
Interval 5.55 to 9.33
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)Population: All treated Cohort B, C participants. (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of first treatment. Pre-specified only to be collected for Cohorts B and C.
Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first. Radiographic progression per Investigator assessment: 1. Bone disease progression by Prostate Cancer Working Group (PCWG2) 2. Non-bone soft tissue disease progression by RECIST v1.1 Clinical progression per investigator assessment: 1. Need for palliative radiation therapy involving more than one site, OR 2. Surgery of kyphoplasty to any neoplastic lesion, OR 3. Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C
|
4.34 Months
Interval 2.79 to 5.49
|
3.71 Months
Interval 2.1 to 4.04
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 93 months)Population: All randomized Cohort D participants (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.
Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first. Radiographic progression per Investigator assessment: 1. Bone disease progression by Prostate Cancer Working Group (PCWG2) 2. Non-bone soft tissue disease progression by RECIST v1.1 Clinical progression per investigator assessment: 1. Need for palliative radiation therapy involving more than one site, OR 2. Surgery of kyphoplasty to any neoplastic lesion, OR 3. Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=74 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=74 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D
|
2.53 Months
Interval 2.1 to 3.22
|
3.78 Months
Interval 2.23 to 4.63
|
2.66 Months
Interval 2.04 to 3.71
|
5.85 Months
Interval 3.84 to 7.52
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to the date of death due to any cause (assessed up to approximately 61 months)Population: All treated participants in Cohorts B and C; pre-specified only to be collected for Cohorts B and C.
Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up. Based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) Cohorts B and C
|
19.75 Months
Interval 13.9 to 23.56
|
15.21 Months
Interval 8.44 to 17.77
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to the date of death due to any cause (assessed up to approximately 93 months)Population: All randomized participants in Cohort D.
Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up. Based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=74 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=74 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) Cohort D
|
15.9 Months
Interval 13.14 to 19.29
|
14.46 Months
Interval 10.64 to 17.51
|
18.46 Months
Interval 10.28 to 25.69
|
15.15 Months
Interval 11.56 to 18.56
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)Population: All treated participants with PSA values at baseline and at least one postbaseline assessment in Cohorts B and C. Pre-specified only to be collected for Cohorts B and C.
The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations. Confidence-interval based on Clopper Pearson method.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=34 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=40 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C
|
17.6 Percent of Participants
Interval 6.8 to 34.5
|
10.0 Percent of Participants
Interval 2.8 to 23.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 93 months)Population: All randomized participants with PSA values at baseline and at least one post-baseline assessment in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.
The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations. Confidence-interval based on Clopper Pearson method.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=66 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=66 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=37 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=71 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
n=13 Participants
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
n=23 Participants
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D
|
13.6 Percent of Participants
Interval 6.4 to 24.3
|
18.2 Percent of Participants
Interval 9.8 to 29.6
|
5.4 Percent of Participants
Interval 0.7 to 18.2
|
23.9 Percent of Participants
Interval 14.6 to 35.5
|
30.8 Percent of Participants
Interval 9.1 to 61.4
|
17.4 Percent of Participants
Interval 5.0 to 38.8
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)Population: All treated participants in Cohorts A, B and C
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=2 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=45 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C
|
2 Participants
|
45 Participants
|
45 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)Population: All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=72 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
n=13 Participants
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
n=27 Participants
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Adverse Events (AEs) in Cohort D
|
69 Participants
|
71 Participants
|
37 Participants
|
69 Participants
|
11 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)Population: All treated participants in Cohorts A, B and C
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=2 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=45 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C
|
1 Participants
|
17 Participants
|
33 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)Population: All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=72 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
n=13 Participants
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
n=27 Participants
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D
|
38 Participants
|
44 Participants
|
15 Participants
|
32 Participants
|
7 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)Population: All treated participants in Cohorts A, B and C
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=2 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=45 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C
|
1 Participants
|
17 Participants
|
18 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)Population: All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=72 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
n=13 Participants
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
n=27 Participants
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D
|
16 Participants
|
27 Participants
|
7 Participants
|
13 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months)Population: All treated participants in Cohorts A, B and C.
Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=2 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=45 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Pneumonitis
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Diarrhea/Colitis
|
0 Participants
|
15 Participants
|
17 Participants
|
—
|
—
|
—
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Hepatitis
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Adrenal Insufficiency
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Hypothyroidism/Thyroiditis
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Diabetes Mellitus
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Nephritis and Renal Dysfunction
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Rash
|
0 Participants
|
16 Participants
|
6 Participants
|
—
|
—
|
—
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Hyperthyroidism
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Hypophysitis
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 100 days after last dose of study therapy (an average of 8.48 months assessed up to approximately 29.09 months)Population: All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.
Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=72 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
n=13 Participants
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
n=27 Participants
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Pneumonitis
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Diarrhea/Colitis
|
9 Participants
|
21 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Hepatitis
|
5 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Adrenal Insufficiency
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Hypothyroidism/Thyroiditis
|
6 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Diabetes Mellitus
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Nephritis and Renal Dysfunction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Rash
|
12 Participants
|
10 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Hyperthyroidism
|
4 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Hypophysitis
|
2 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months).Population: All treated participants in Cohorts A, B and C.
Death due to any cause.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=2 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=45 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants Who Died in Cohorts A, B and C
|
2 Participants
|
39 Participants
|
39 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 100 days after last dose of study therapy (an average of 8.48 months assessed up to approximately 29.09 months)Population: All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.
Death due to any cause.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=72 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
n=13 Participants
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
n=27 Participants
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants Who Died in Cohort D
|
14 Participants
|
15 Participants
|
4 Participants
|
13 Participants
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)Population: All treated participants in Cohorts A, B and C with baseline laboratory measurements.
The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=2 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=33 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=45 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Platelet Count
|
0 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Leukocytes
|
0 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Lymphocytes (Absolute)
|
0 Participants
|
9 Participants
|
17 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Absolute Neutrophil Count
|
0 Participants
|
0 Participants
|
6 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Alkaline Phosphatase
|
0 Participants
|
7 Participants
|
15 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Aspartate Aminotransferase
|
0 Participants
|
9 Participants
|
17 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Alanine Aminotransferase
|
1 Participants
|
5 Participants
|
14 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Bilirubin, Total
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Creatinine
|
0 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Amylase, Total
|
0 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Lipase, Total
|
0 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Hypernatremia
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Hyponatremia
|
0 Participants
|
8 Participants
|
15 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Hyperkalemia
|
0 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Hypokalemia
|
0 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Hypercalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Hypocalcemia
|
0 Participants
|
4 Participants
|
12 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Hyperglycemia
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Hypoglycemia
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Hemoglobin
|
0 Participants
|
6 Participants
|
23 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)Population: All treated participants in Cohort D with baseline laboratory measurements. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.
The number of participants with an change in laboratory values from baseline Grade in Cohort D.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=71 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=67 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=37 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=71 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Hemoglobin
|
26 Participants
|
35 Participants
|
14 Participants
|
42 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Platelet Count
|
10 Participants
|
8 Participants
|
2 Participants
|
15 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Leukocytes
|
8 Participants
|
9 Participants
|
3 Participants
|
25 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Lymphocytes (Absolute)
|
28 Participants
|
31 Participants
|
9 Participants
|
37 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Absolute Neutrophil Count
|
7 Participants
|
7 Participants
|
2 Participants
|
18 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Alkaline Phosphatase
|
23 Participants
|
18 Participants
|
12 Participants
|
14 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Aspartate Aminotransferase
|
17 Participants
|
21 Participants
|
5 Participants
|
11 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Alanine Aminotransferase
|
21 Participants
|
24 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Bilirubin, Total
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Creatinine
|
20 Participants
|
15 Participants
|
2 Participants
|
14 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Amylase, Total
|
13 Participants
|
16 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Lipase, Total
|
17 Participants
|
16 Participants
|
7 Participants
|
8 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Hypernatremia
|
4 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Hyponatremia
|
21 Participants
|
12 Participants
|
7 Participants
|
12 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Hyperkalemia
|
7 Participants
|
12 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Hypokalemia
|
5 Participants
|
8 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Hypercalcemia
|
2 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Hypocalcemia
|
12 Participants
|
23 Participants
|
14 Participants
|
18 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Hyperglycemia
|
1 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
|
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Hypoglycemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)Population: All Treated Participants in Cohorts A, B and C with at least one on-treatment liver function measurement.
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=1 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=31 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=43 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
ALT OR AST > 3XULN
|
0 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
ALT OR AST> 5XULN
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
ALT OR AST> 10XULN
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
ALT OR AST > 20XULN
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
TOTAL BILIRUBIN > 2XULN
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)Population: All Treated Participants in Cohort D with at least one on-treatment liver function measurement. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=71 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=65 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=37 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=71 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
ALT OR AST > 3XULN
|
6 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
ALT OR AST> 5XULN
|
3 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
ALT OR AST> 10XULN
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>1.5XULN WITHIN 1 DAY
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>1.5XULN WITHIN 30 DAYS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>2XULN WITHIN 1 DAY
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>2XULN WITHIN 30 DAYS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
ALT OR AST > 20XULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
TOTAL BILIRUBIN > 2XULN
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
ALP>1.5XULN
|
23 Participants
|
24 Participants
|
15 Participants
|
17 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)Population: Treated participants in Cohorts A, B and C with at least one on-treatment TSH measurement. Treated subjects in Cohort B with adequate follow-up of at least 24 weeks are included.
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=1 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=29 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=41 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
TSH > ULN
|
0 Participants
|
5 Participants
|
13 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
TSH > ULN WITH TSH <= ULN AT BASELINE
|
0 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
|
0 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
TSH > ULN WITH FT3/FT4 TEST MISSING
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
TSH < LLN
|
0 Participants
|
7 Participants
|
10 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
TSH <LLN WITH TSH >= LLN AT BASELINE
|
0 Participants
|
6 Participants
|
10 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
|
0 Participants
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
TSH < LLN WITH FT3/FT4 TEST MISSING
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)Population: Treated participants in Cohort D with at least one on-treatment TSH measurement. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=70 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=62 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=37 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=71 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
TSH > ULN
|
13 Participants
|
20 Participants
|
1 Participants
|
11 Participants
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
TSH > ULN WITH TSH <= ULN AT BASELINE
|
10 Participants
|
16 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
|
6 Participants
|
12 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
|
6 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
TSH > ULN WITH FT3/FT4 TEST MISSING
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
TSH < LLN
|
22 Participants
|
22 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
TSH <LLN WITH TSH >= LLN AT BASELINE
|
22 Participants
|
20 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
|
9 Participants
|
9 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
|
13 Participants
|
11 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
|
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
TSH < LLN WITH FT3/FT4 TEST MISSING
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and Week 4 (Cycle 2)Population: All treated Cohort B and C participants with baseline and week 4 (cycle 2) scores. Pre-specified only to be collected for Cohorts B and C.
Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=21 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=29 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C
Worst pain in the last 24 hours Week 4 (Cycle 2)
|
0.0 Score on a scale
Interval -4.0 to 5.0
|
-0.1 Score on a scale
Interval -5.0 to 6.0
|
—
|
—
|
—
|
—
|
|
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C
Least pain in the last 24 hours Week 4 (Cycle 2)
|
-0.5 Score on a scale
Interval -3.0 to 1.0
|
-0.1 Score on a scale
Interval -3.0 to 3.0
|
—
|
—
|
—
|
—
|
|
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C
Average pain in the last 24 hours Week 4 (Cycle 2)
|
-0.2 Score on a scale
Interval -3.0 to 2.0
|
-0.1 Score on a scale
Interval -4.0 to 2.0
|
—
|
—
|
—
|
—
|
|
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C
Current pain Week 4 (Cycle 2)
|
-0.1 Score on a scale
Interval -3.0 to 2.0
|
0 Score on a scale
Interval -5.0 to 4.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and 4 weeks after first dose.Population: All randomized Cohort D participants with baseline and week 4 scores
Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=54 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=47 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=34 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=61 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D
Worst pain in the last 24 hours Week 4
|
-0.3 Score on a scale
Interval -7.0 to 8.0
|
0.5 Score on a scale
Interval -5.0 to 7.0
|
-0.1 Score on a scale
Interval -8.0 to 6.0
|
-0.5 Score on a scale
Interval -7.0 to 5.0
|
—
|
—
|
|
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D
Least pain in the last 24 hours Week 4
|
-0.3 Score on a scale
Interval -7.0 to 8.0
|
0.2 Score on a scale
Interval -4.0 to 4.0
|
0.2 Score on a scale
Interval -4.0 to 5.0
|
-0.3 Score on a scale
Interval -5.0 to 3.0
|
—
|
—
|
|
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D
Average pain in the last 24 hours Week 4
|
-0.5 Score on a scale
Interval -6.0 to 6.0
|
0.2 Score on a scale
Interval -5.0 to 6.0
|
-0.3 Score on a scale
Interval -5.0 to 5.0
|
-0.4 Score on a scale
Interval -5.0 to 3.0
|
—
|
—
|
|
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D
Current pain Week 4
|
-0.2 Score on a scale
Interval -6.0 to 6.0
|
0.3 Score on a scale
Interval -4.0 to 4.0
|
-0.4 Score on a scale
Interval -6.0 to 6.0
|
-0.3 Score on a scale
Interval -6.0 to 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and 4 weeks after first dose.Population: All randomized Cohort D participants with baseline and week 4 scores; pre-specified for data to be collected only from Cohort D participants.
The Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a multidimensional, self-report Quality of Life (QoL) instrument designed for use with prostate cancer patients. It consists of 27 core items. The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which assesses patient function in 4 domains: Physical, Social/Family, Emotional, and Functional well-being. This is further supplemented by the Prostate Cancer Subscale (PCS), 12 disease-specific items to assess for prostate-related symptoms. Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores for each domain, a Trial Outcome Index which is based on the Physical and Functional well-being scales and the PCS as well as a total score which ranges from 0 to 156. Higher scores represent better QoL. Baseline evaluations or events were defined as those that occur before or on the date and time of the first dose of study treatment.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=57 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=48 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=35 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=64 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D
|
6.73 Score on a scale
Interval -60.2 to 116.4
|
-4.74 Score on a scale
Interval -81.0 to 72.7
|
-3.64 Score on a scale
Interval -91.5 to 65.0
|
-0.28 Score on a scale
Interval -71.7 to 53.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and at Week 4 of Cycle 2.Population: All treated Cohort B and C participants with baseline and week 4 (cycle 2) scores. Pre-specified only to be collected for Cohorts B and C.
The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=20 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=26 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C
|
0.0083 Score on a scale
Interval -0.311 to 0.275
|
-0.0074 Score on a scale
Interval -0.327 to 0.628
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and 4 weeks after first dose.Population: All randomized Cohort D participants with baseline and week 4 scores
The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=54 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=33 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=62 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D
|
0.0032 Score on a scale
Interval -0.736 to 0.791
|
-0.0328 Score on a scale
Interval -0.574 to 0.532
|
0.0113 Score on a scale
Interval -0.532 to 0.463
|
0.0219 Score on a scale
Interval -0.514 to 0.697
|
—
|
—
|
POST_HOC outcome
Timeframe: From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 93 months)Population: All randomized Cohort D participants with measurable disease at baseline. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.
In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=46 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=23 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=45 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Cohort D
|
13.3 Percent of Participants
Interval 5.1 to 26.8
|
17.4 Percent of Participants
Interval 7.8 to 31.4
|
8.7 Percent of Participants
Interval 1.1 to 28.0
|
8.9 Percent of Participants
Interval 2.5 to 21.2
|
—
|
—
|
POST_HOC outcome
Timeframe: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 93 months)Population: All randomized Cohort D participants (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.
Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first. The following progressive diseases were collected, documented and assessed as below: Radiographic progression per BICR assessment 1. Bone disease progression by (Prostate Cancer Working Group) PCWG2 2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=73 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=74 Participants
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 Participants
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=74 Participants
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Radiographic Progression-Free Survival (rPFS) for Cohort D
|
3.70 Months
Interval 2.37 to 5.36
|
3.81 Months
Interval 2.23 to 4.63
|
3.09 Months
Interval 2.04 to 4.37
|
6.34 Months
Interval 5.22 to 8.31
|
—
|
—
|
Adverse Events
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Serious events: 37 serious events
Other events: 44 other events
Deaths: 40 deaths
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Serious events: 39 serious events
Other events: 45 other events
Deaths: 41 deaths
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W
Serious events: 44 serious events
Other events: 66 other events
Deaths: 67 deaths
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W
Serious events: 50 serious events
Other events: 64 other events
Deaths: 65 deaths
Cohort D Arm 3: Ipilimumab 3 mg/kg
Serious events: 25 serious events
Other events: 37 other events
Deaths: 28 deaths
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
Serious events: 50 serious events
Other events: 71 other events
Deaths: 49 deaths
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
Serious events: 9 serious events
Other events: 10 other events
Deaths: 9 deaths
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
Serious events: 20 serious events
Other events: 25 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=2 participants at risk
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 participants at risk
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 participants at risk
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W
n=73 participants at risk
Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W
n=73 participants at risk
Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 participants at risk
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=72 participants at risk
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
n=13 participants at risk
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
n=27 participants at risk
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.3%
6/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Immune-mediated hypothyroidism
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Thyroiditis
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
20.0%
9/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.6%
7/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.6%
7/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Overflow diarrhoea
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Terminal ileitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Asthenia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Death
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Disease progression
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Sudden death
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Cystitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Eye infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Septic shock
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Nerve root injury
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Urinary tract procedural complication
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Blood urine present
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Transaminases increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Troponin T increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Joint neoplasm
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.1%
11/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.0%
8/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
25.0%
18/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
22.2%
6/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Cerebellar stroke
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Cerebral haemorrhage
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Autoimmune lung disease
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmalgia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Vascular disorders
Haematoma
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Vascular disorders
Iliac vein occlusion
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
Other adverse events
| Measure |
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=2 participants at risk
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 participants at risk
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=45 participants at risk
Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.
|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W
n=73 participants at risk
Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W
n=73 participants at risk
Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.
|
Cohort D Arm 3: Ipilimumab 3 mg/kg
n=38 participants at risk
Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg
n=72 participants at risk
Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3
n=13 participants at risk
Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4
n=27 participants at risk
Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
28.9%
13/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
31.1%
14/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.7%
10/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
20.5%
15/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
23.7%
9/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
36.1%
26/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
30.8%
4/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
22.2%
6/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
8/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.9%
5/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Cardiac disorders
Tachycardia
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.3%
6/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
20.0%
9/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
12.3%
9/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
3/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Eye disorders
Eyelid haematoma
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Eye disorders
Vision blurred
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.6%
7/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
10.5%
4/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.3%
6/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
37.8%
17/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
33.3%
15/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
17.8%
13/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.6%
7/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
28.9%
11/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
27.8%
20/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
14.8%
4/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
51.1%
23/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
62.2%
28/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
32.9%
24/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
35.6%
26/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
39.5%
15/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
33.3%
24/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
30.8%
4/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
18.5%
5/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.6%
7/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.3%
6/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.3%
6/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.9%
5/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
28.9%
13/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
42.2%
19/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
24.7%
18/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
23.3%
17/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
23.7%
9/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
38.9%
28/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
29.6%
8/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
17.8%
8/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
35.6%
16/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
16.4%
12/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.7%
10/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
10.5%
4/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
16.7%
12/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
14.8%
4/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Asthenia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.6%
7/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.8%
6/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.3%
11/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
18.5%
5/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
62.2%
28/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
68.9%
31/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
28.8%
21/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
27.4%
20/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
39.5%
15/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
43.1%
31/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
18.5%
5/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
17.8%
8/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.3%
6/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.6%
7/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
18.4%
7/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.3%
11/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
14.8%
4/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
12.3%
9/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.9%
10/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
14.8%
4/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
20.0%
9/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
31.1%
14/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.6%
7/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.8%
6/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
8/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
14.8%
4/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.9%
5/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Injury, poisoning and procedural complications
Stoma site pruritus
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Amylase increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.3%
6/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.6%
7/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.0%
8/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.1%
11/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.7%
7/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
3/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Lipase increased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
3/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
Weight decreased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
20.0%
9/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.1%
11/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.3%
6/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
33.3%
15/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
64.4%
29/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
23.3%
17/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
19.2%
14/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
39.5%
15/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
27.8%
20/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
23.1%
3/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
25.9%
7/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.3%
6/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.0%
8/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
3/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.3%
6/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.6%
7/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.7%
10/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
24.4%
11/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
22.2%
10/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
27.4%
20/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.1%
11/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
26.3%
10/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
12.5%
9/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
23.1%
3/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
20.0%
9/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.1%
11/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.0%
8/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
26.3%
10/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
22.2%
16/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
14.8%
4/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
8/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.3%
6/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.3%
6/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.6%
7/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.9%
5/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
12.5%
9/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.3%
6/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.1%
11/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.0%
8/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
20.0%
9/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.6%
7/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
10.5%
4/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
8/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
3/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.9%
5/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.6%
7/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
10.5%
4/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.7%
7/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
8/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.7%
7/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Presyncope
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Psychiatric disorders
Agitation
|
100.0%
2/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
5/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
12.5%
9/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.9%
3/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
18.1%
13/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
28.9%
13/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
17.8%
8/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.6%
7/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.3%
6/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.1%
3/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
20.0%
9/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.6%
7/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.2%
6/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
18.4%
7/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.9%
10/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
14.8%
4/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.2%
3/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.4%
2/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
26.7%
12/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.3%
6/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
17.8%
13/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.7%
10/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
26.3%
10/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.7%
7/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.4%
2/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
18.5%
5/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
20.0%
9/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.6%
7/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
13.7%
10/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
9.6%
7/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
15.8%
6/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.3%
6/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
18.5%
5/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
24.4%
11/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
22.2%
10/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
11.0%
8/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.8%
5/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
14.8%
4/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Vascular disorders
Flushing
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Vascular disorders
Hot flush
|
50.0%
1/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
6.7%
3/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.7%
2/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.6%
4/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.2%
1/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.4%
2/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
8.9%
4/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
4.1%
3/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.5%
4/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
5.3%
2/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.8%
2/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
3.7%
1/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/2 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/45 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/73 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
2.6%
1/38 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
1.4%
1/72 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
7.7%
1/13 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
0.00%
0/27 • Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).
The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: 1(800) 332-2056
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER