Trial Outcomes & Findings for A Study of Ponsegromab in People With Heart Failure (NCT NCT05492500)
NCT ID: NCT05492500
Last Updated: 2026-03-18
Results Overview
KCCQ is a self-reported 23-item questionnaire that assessed health related quality of life (HRQL) in participants with heart failure (HF) over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ total symptom score (TSS): mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
455 participants
Primary outcome timeframe
Baseline [the last measurement on study Day 1], Week 22
Results posted on
2026-03-18
Participant Flow
A total of 455 participants were enrolled, randomized and treated in this study: 433 participants in cohort A and 22 participants in cohort B.
The following cohorts were planned for the study: Cohort A, Cohort B, Cohort C and Cohort D. No participants were enrolled either in Cohort C or Cohort D due to study termination and data for these cohorts is not reported in any section of the record.
Participant milestones
| Measure |
Cohort A: Placebo
Participants in Cohort A were randomized to receive placebo matched to ponsegromab subcutaneously (SC), once in every 4 weeks (Q4W) from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 100mg
Participants in Cohort A were randomized to receive ponsegromab 100 milligrams (mg), Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort B: Ponsegromab 100mg
Participants in Cohort B were randomized to receive ponsegromab 100 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Cohort B: Ponsegromab 200mg
Participants in Cohort B were randomized to receive ponsegromab 200 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Cohort B: Ponsegromab 300mg
Participants in Cohort B were randomized to receive ponsegromab 300 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
|---|---|---|---|---|---|---|---|
|
Cohort A: Double-Blind Treatment
STARTED
|
198
|
21
|
17
|
197
|
0
|
0
|
0
|
|
Cohort A: Double-Blind Treatment
COMPLETED
|
154
|
17
|
16
|
161
|
0
|
0
|
0
|
|
Cohort A: Double-Blind Treatment
NOT COMPLETED
|
44
|
4
|
1
|
36
|
0
|
0
|
0
|
|
Cohort B: Open Label Treatment
STARTED
|
0
|
0
|
0
|
0
|
5
|
9
|
8
|
|
Cohort B: Open Label Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
2
|
8
|
6
|
|
Cohort B: Open Label Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort A: Placebo
Participants in Cohort A were randomized to receive placebo matched to ponsegromab subcutaneously (SC), once in every 4 weeks (Q4W) from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 100mg
Participants in Cohort A were randomized to receive ponsegromab 100 milligrams (mg), Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort B: Ponsegromab 100mg
Participants in Cohort B were randomized to receive ponsegromab 100 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Cohort B: Ponsegromab 200mg
Participants in Cohort B were randomized to receive ponsegromab 200 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Cohort B: Ponsegromab 300mg
Participants in Cohort B were randomized to receive ponsegromab 300 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
|---|---|---|---|---|---|---|---|
|
Cohort A: Double-Blind Treatment
Adverse Event
|
7
|
2
|
0
|
4
|
0
|
0
|
0
|
|
Cohort A: Double-Blind Treatment
Death
|
10
|
0
|
1
|
9
|
0
|
0
|
0
|
|
Cohort A: Double-Blind Treatment
Study terminated by sponsor
|
21
|
0
|
0
|
20
|
0
|
0
|
0
|
|
Cohort A: Double-Blind Treatment
Withdrawal by Subject
|
6
|
1
|
0
|
3
|
0
|
0
|
0
|
|
Cohort A: Double-Blind Treatment
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Cohort B: Open Label Treatment
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
|
Cohort B: Open Label Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Cohort B: Open Label Treatment
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Ponsegromab in People With Heart Failure
Baseline characteristics by cohort
| Measure |
Cohort A: Placebo
n=198 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 100mg
n=21 Participants
Participants in Cohort A were randomized to receive ponsegromab 100 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=17 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=197 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort B: Ponsegromab 100mg
n=5 Participants
Participants in Cohort B were randomized to receive ponsegromab 100 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Cohort B: Ponsegromab 200mg
n=9 Participants
Participants in Cohort B were randomized to receive ponsegromab 200 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Cohort B: Ponsegromab 300mg
n=8 Participants
Participants in Cohort B were randomized to receive ponsegromab 300 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Less than (<) 55 years
|
7 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
5 Participants
n=104 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=14 Participants
|
16 Participants
n=52 Participants
|
|
Age, Customized
55-64 years
|
19 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
21 Participants
n=104 Participants
|
4 Participants
n=2 Participants
|
5 Participants
n=2 Participants
|
2 Participants
n=14 Participants
|
57 Participants
n=52 Participants
|
|
Age, Customized
65-74 years
|
63 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
7 Participants
n=224 Participants
|
63 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=14 Participants
|
146 Participants
n=52 Participants
|
|
Age, Customized
75-84 years
|
83 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
4 Participants
n=224 Participants
|
83 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=14 Participants
|
177 Participants
n=52 Participants
|
|
Age, Customized
More than or equal to (>=) 85 years
|
26 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
4 Participants
n=224 Participants
|
25 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
59 Participants
n=52 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
4 Participants
n=224 Participants
|
40 Participants
n=104 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=14 Participants
|
110 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=110 Participants
|
13 Participants
n=114 Participants
|
13 Participants
n=224 Participants
|
157 Participants
n=104 Participants
|
4 Participants
n=2 Participants
|
9 Participants
n=2 Participants
|
6 Participants
n=14 Participants
|
345 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
41 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
79 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=110 Participants
|
17 Participants
n=114 Participants
|
15 Participants
n=224 Participants
|
153 Participants
n=104 Participants
|
5 Participants
n=2 Participants
|
9 Participants
n=2 Participants
|
8 Participants
n=14 Participants
|
372 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
3 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
4 Participants
n=52 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Asian
|
43 Participants
n=110 Participants
|
10 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
51 Participants
n=104 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
110 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
6 Participants
n=104 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=14 Participants
|
13 Participants
n=52 Participants
|
|
Race (NIH/OMB)
White
|
152 Participants
n=110 Participants
|
9 Participants
n=114 Participants
|
12 Participants
n=224 Participants
|
139 Participants
n=104 Participants
|
2 Participants
n=2 Participants
|
7 Participants
n=2 Participants
|
7 Participants
n=14 Participants
|
328 Participants
n=52 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
1 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
3 Participants
n=52 Participants
|
PRIMARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set: randomized participants who took \>=1 dose of study drug. Participants who discontinued study drug or got a prohibited procedure; or missed dose, or got an incomplete dose, all observations post-discontinuation/procedure; post-missed/incomplete dose respectively, were censored. Participants who resumed dosing, their subsequent data usage in analysis was post review of their compliance prior to database lock. "Overall Number of Participants Analyzed": evaluable participants.
KCCQ is a self-reported 23-item questionnaire that assessed health related quality of life (HRQL) in participants with heart failure (HF) over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ total symptom score (TSS): mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=147 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=146 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 - Clinical Summary Score (CSS) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
|
7.56 Units on a Scale
Interval 5.29 to 9.82
|
—
|
—
|
7.24 Units on a Scale
Interval 4.96 to 9.53
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=16 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=15 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=147 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=146 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in KCCQ-23 CSS at Week 22: Cohort A
|
5.57 Units on a Scale
Standard Deviation 23.491
|
6.25 Units on a Scale
Standard Deviation 18.179
|
8.31 Units on a Scale
Standard Deviation 19.277
|
7.21 Units on a Scale
Standard Deviation 17.931
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=147 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=146 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in KCCQ-23-Overall Summary Score (OSS) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
|
7.76 Units on a Scale
Interval 5.49 to 10.03
|
—
|
—
|
8.04 Units on a Scale
Interval 5.76 to 10.33
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=16 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=15 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=147 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=146 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in KCCQ-23 OSS at Week 22: Cohort A
|
7.22 Units on a Scale
Standard Deviation 22.525
|
5.38 Units on a Scale
Standard Deviation 17.262
|
8.23 Units on a Scale
Standard Deviation 20.355
|
7.91 Units on a Scale
Standard Deviation 17.597
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=147 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=146 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in KCCQ-23-TSS at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
|
8.41 Units on a Scale
Interval 6.14 to 10.67
|
—
|
—
|
7.51 Units on a Scale
Interval 5.23 to 9.79
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=16 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=15 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=147 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=146 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in KCCQ-23 TSS at Week 22: Cohort A
|
6.45 Score on a Scale
Standard Deviation 32.150
|
5.00 Score on a Scale
Standard Deviation 22.255
|
8.79 Score on a Scale
Standard Deviation 20.075
|
7.46 Score on a Scale
Standard Deviation 18.042
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=143 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=143 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in KCCQ-23 Physical Limitation Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
|
6.47 Units on a Scale
Interval 3.75 to 9.2
|
—
|
—
|
6.63 Units on a Scale
Interval 3.89 to 9.38
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=16 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=15 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=143 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=143 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in KCCQ-23 Physical Limitation Score at Week 22: Cohort A
|
4.69 Units on a Scale
Standard Deviation 21.907
|
7.50 Units on a Scale
Standard Deviation 19.768
|
7.63 Units on a Scale
Standard Deviation 23.102
|
6.72 Units on a Scale
Standard Deviation 22.116
|
SECONDARY outcome
Timeframe: Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Multiple imputation was used for missing data.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=197 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=198 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23-CSS at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
|
54.5 Percentage of Participants
Interval 3.75 to 9.2
|
—
|
—
|
53.6 Percentage of Participants
Interval 3.89 to 9.38
|
SECONDARY outcome
Timeframe: Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. No imputation technique was applied.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=16 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=15 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=147 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=146 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 CSS Score at Week 22: Cohort A
|
56.3 Percentage of Participants
Interval 21.907 to
|
66.7 Percentage of Participants
Interval 19.768 to
|
59.9 Percentage of Participants
Interval 23.102 to
|
55.5 Percentage of Participants
Interval 22.116 to
|
SECONDARY outcome
Timeframe: Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Multiple imputation was used for missing data.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=197 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=198 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 OSS Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
|
52.1 Percentage of Participants
Interval 3.75 to 9.2
|
—
|
—
|
51.5 Percentage of Participants
Interval 3.89 to 9.38
|
SECONDARY outcome
Timeframe: Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. No imputation technique was applied.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=16 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=15 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=147 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=146 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 OSS Score at Week 22: Cohort A
|
62.5 Percentage of Participants
Interval 21.907 to
|
66.7 Percentage of Participants
Interval 19.768 to
|
56.5 Percentage of Participants
Interval 23.102 to
|
52.7 Percentage of Participants
Interval 22.116 to
|
SECONDARY outcome
Timeframe: Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Multiple imputation was used for missing data.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=197 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=198 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 TSS Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
|
56.7 Percentage of Participants
Interval 3.75 to 9.2
|
—
|
—
|
51.0 Percentage of Participants
Interval 3.89 to 9.38
|
SECONDARY outcome
Timeframe: Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. No imputation technique was applied.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=16 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=15 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=147 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=146 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 TSS Score at Week 22: Cohort A
|
56.3 Percentage of Participants
Interval 21.907 to
|
60.0 Percentage of Participants
Interval 19.768 to
|
61.9 Percentage of Participants
Interval 23.102 to
|
52.7 Percentage of Participants
Interval 22.116 to
|
SECONDARY outcome
Timeframe: Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Multiple imputation was used for missing data.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=197 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=198 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 PL Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
|
50.6 Percentage of Participants
Interval 3.75 to 9.2
|
—
|
—
|
49.9 Percentage of Participants
Interval 3.89 to 9.38
|
SECONDARY outcome
Timeframe: Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. No imputation technique was applied.
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=16 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=15 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=143 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=143 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 PL Score at Week 22: Cohort A
|
56.3 Percentage of Participants
Interval 21.907 to
|
46.7 Percentage of Participants
Interval 19.768 to
|
55.9 Percentage of Participants
Interval 23.102 to
|
51.0 Percentage of Participants
Interval 22.116 to
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The 6-minute walk test (6MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWD (distance travelled in meters) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=151 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=145 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
|
15.40 Meters
Interval 6.37 to 24.42
|
—
|
—
|
11.92 Meters
Interval 2.73 to 21.1
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWD (distance travelled in meters) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=13 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=15 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=151 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=145 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in 6MWD at Week 22: Cohort A
|
17.0 Meters
Standard Deviation 62.17
|
-9.7 Meters
Standard Deviation 111.32
|
18.7 Meters
Standard Deviation 72.13
|
11.3 Meters
Standard Deviation 69.54
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The PROMIS Fatigue 7a is a self-reported measure that assessed a range of symptoms in the past 7 days from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The short form (SF) 7A consisted of 7 items that study participants rated from 1: "Never" to 5: "Always". A global raw score ranged from 7 to 35 was calculated and translated into a T-score with minimum of 29.4 and maximum of 83.2 (mean = 50, a standard deviation \[SD\] = 10) using the applicable score conversion provided in the PROMIS user's manual. Higher scores indicated more fatigue.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=161 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=153 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue (Version 7a) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
|
-2.88 T-score
Interval -3.87 to -1.88
|
—
|
—
|
-1.99 T-score
Interval -3.02 to -0.97
|
SECONDARY outcome
Timeframe: Baseline [the last measurement on study Day 1], Week 22Population: Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The PROMIS Fatigue 7a is a self-reported measure that assessed a range of symptoms in the past 7 days from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The short form (SF) 7A consisted of 7 items that study participants rated from 1: "Never" to 5: "Always". A global raw score ranged from 7 to 35 was calculated and translated into a T-score (mean = 50, a standard deviation \[SD\] = 10) using the applicable score conversion provided in the PROMIS user's manual. Higher scores indicated more fatigue.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=16 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=15 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=161 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=153 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in PROMIS Fatigue (Version 7a) at Week 22: Cohort A
|
-2.99 T-score
Standard Deviation 9.996
|
-1.38 T-score
Standard Deviation 7.981
|
-3.28 T-score
Standard Deviation 8.407
|
-1.66 T-score
Standard Deviation 8.278
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. TESAE was a TEAE which met the definition of serious adverse event (SAE) viz. any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was considered an important medical event. AEs included SAEs and all other AEs (non-SAEs).
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=21 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=17 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=197 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=198 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs): Cohort A
TEAEs
|
18 Participants
|
14 Participants
|
158 Participants
|
149 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs): Cohort A
TESAEs
|
7 Participants
|
7 Participants
|
69 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to Week 22Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Laboratory parameters included were: hematology (hemoglobin, hematocrit, red blood cells \[RBC\] count, platelet count, white blood cells \[WBC\] count) and chemistry (urea and creatinine, estimated glomerular filtration rate \[eGFR\], cystatin C \[at baseline only\], sodium, potassium, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase \[ALP\], total protein, glucose \[non-fasting\] and lipid panel, total cholesterol, high-density lipoprotein \[HDL\] cholesterol, Non HDL cholesterol, calculated low-density lipoprotein \[LDL\] cholesterol and triglycerides. Number of participants with any abnormalities in laboratory test parameters as judged by investigator were reported.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=19 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=16 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=191 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=189 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Number of Participants With Any Abnormalities in Laboratory Test Parameters: Cohort A
|
14 Participants
|
10 Participants
|
144 Participants
|
111 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Vital signs abnormalities criteria included: supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), increase and decrease in change of \>= 30mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, increase and decrease in change of \>=20mmHg; and pulse rate (PR) \<40 beats per minute (bpm) and \>120 bpm.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=21 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=17 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=197 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=196 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Vital Signs: Cohort A
Supine SBP: change >= 30mmHg increase
|
5 Participants
|
1 Participants
|
29 Participants
|
18 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort A
Supine SBP: value <90mmHg
|
4 Participants
|
4 Participants
|
43 Participants
|
49 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort A
Supine SBP: change >= 30mmHg decrease
|
2 Participants
|
5 Participants
|
27 Participants
|
20 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort A
Supine DBP: value <50mmHg
|
3 Participants
|
1 Participants
|
41 Participants
|
46 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort A
Supine DBP: change >=20mmHg increase
|
6 Participants
|
1 Participants
|
23 Participants
|
28 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort A
Supine DBP: change >=20mmHg decrease
|
2 Participants
|
2 Participants
|
30 Participants
|
21 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort A
PR: value <40 bpm
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort A
PR: value >120 bpm
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. TESAE was a TEAE which met the definition of SAE viz. any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was considered an important medical event. AEs included SAEs and all other AEs (non-SAEs).
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=9 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=8 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=5 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs and TEASAEs: Cohort B
TEAEs
|
4 Participants
|
6 Participants
|
—
|
2 Participants
|
|
Number of Participants With TEAEs and TEASAEs: Cohort B
TESAEs
|
1 Participants
|
2 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) maximum up to 4 weeks post Week 12 (maximum up to approximately 16 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Laboratory parameters included were: hematology (hemoglobin, hematocrit, RBC count, platelet count, WBC count) and chemistry (urea and creatinine, eGFR, cystatin C \[at baseline only\], sodium, potassium, AST, ALT, total bilirubin, ALP, total protein, glucose \[non-fasting\] and lipid panel, total cholesterol, HDL cholesterol, Non HDL cholesterol, calculated LDL cholesterol and triglycerides. Number of participants with any abnormalities in laboratory test parameters as judged by investigator were reported.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=9 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=7 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=4 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Number of Participants With Any Abnormalities in Laboratory Test Parameters: Cohort B
|
7 Participants
|
5 Participants
|
—
|
3 Participants
|
SECONDARY outcome
Timeframe: From start of study drug on Day 1 maximum up to 4weeks post last dose on Week 12 (maximum up to approximately Week 16)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Vital signs criteria included: supine SBP \<90 mmHg, increase and decrease in change of \>= 30mmHg; supine DBP \<50 mmHg, increase and decrease in change of \>=20mmHg; and PR \<40 bpm to \>120 bpm.
Outcome measures
| Measure |
Cohort A: Ponsegromab 300mg
n=9 Participants
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=8 Participants
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Placebo
n=5 Participants
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Vital Signs: Cohort B
Supine SBP: change >= 30mmHg decrease
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort B
Supine DBP: value <50mmHg
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort B
Supine SBP: value <90mmHg
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort B
Supine SBP: change >= 30mmHg increase
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort B
Supine DBP: change >=20mmHg increase
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort B
Supine DBP: change >=20mmHg decrease
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort B
PR: value <40 bpm
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants With Abnormalities in Vital Signs: Cohort B
PR: value >120 bpm
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
Adverse Events
Cohort A: Placebo
Serious events: 55 serious events
Other events: 94 other events
Deaths: 17 deaths
Cohort A: Ponsegromab 100mg
Serious events: 7 serious events
Other events: 15 other events
Deaths: 2 deaths
Cohort A: Ponsegromab 200mg
Serious events: 7 serious events
Other events: 11 other events
Deaths: 1 deaths
Cohort A: Ponsegromab 300mg
Serious events: 69 serious events
Other events: 102 other events
Deaths: 13 deaths
Cohort B: Ponsegromab 100mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B: Ponsegromab 200mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B: Ponsegromab 300mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort A: Placebo
n=198 participants at risk
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 100mg
n=21 participants at risk
Participants in Cohort A were randomized to receive ponsegromab 100 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=17 participants at risk
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=197 participants at risk
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort B: Ponsegromab 100mg
n=5 participants at risk
Participants in Cohort B were randomized to receive ponsegromab 100 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Cohort B: Ponsegromab 200mg
n=9 participants at risk
Participants in Cohort B were randomized to receive ponsegromab 200 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Cohort B: Ponsegromab 300mg
n=8 participants at risk
Participants in Cohort B were randomized to receive ponsegromab 300 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
2.0%
4/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Arrhythmic storm
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac failure
|
9.6%
19/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.8%
2/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
15.7%
31/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac failure acute
|
1.5%
3/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.1%
8/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac failure chronic
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.8%
2/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiogenic shock
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Pericardial effusion
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Ascites
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Death
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Sudden cardiac death
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Sudden death
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Bacteraemia
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Bacterial infection
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Bronchitis
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Cellulitis
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Diabetic foot infection
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Diverticulitis
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Medical device site cellulitis
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.6%
9/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia bacterial
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Postoperative wound infection
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Respiratory tract infection
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Septic shock
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Urosepsis
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Investigations
Anion gap
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Cerebral infarction
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Syncope
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Psychiatric disorders
Mental status changes
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Haematuria
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Renal failure
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Vascular disorders
Hypotension
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Vascular disorders
Shock
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Investigations
Troponin I increased
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.1%
1/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Cohort A: Placebo
n=198 participants at risk
Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 100mg
n=21 participants at risk
Participants in Cohort A were randomized to receive ponsegromab 100 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 200mg
n=17 participants at risk
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort A: Ponsegromab 300mg
n=197 participants at risk
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
Cohort B: Ponsegromab 100mg
n=5 participants at risk
Participants in Cohort B were randomized to receive ponsegromab 100 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Cohort B: Ponsegromab 200mg
n=9 participants at risk
Participants in Cohort B were randomized to receive ponsegromab 200 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
Cohort B: Ponsegromab 300mg
n=8 participants at risk
Participants in Cohort B were randomized to receive ponsegromab 300 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
4/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
3.6%
7/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.1%
1/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac failure
|
14.6%
29/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
42.9%
9/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
14.7%
29/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.5%
3/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
2.0%
4/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Tachycardia
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
11/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.8%
2/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.6%
11/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
4/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.5%
3/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Asthenia
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Chest pain
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
3.6%
7/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
2.0%
4/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
2.0%
4/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
20.0%
1/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Injection site reaction
|
2.0%
4/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
3.0%
6/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Pain
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Oedema peripheral
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
2.5%
5/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.1%
1/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Bronchitis
|
2.0%
4/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
2.0%
4/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Influenza
|
2.0%
4/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.5%
3/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
11/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.5%
3/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
20.0%
1/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
25.0%
2/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
8/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
14.3%
3/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
7.1%
14/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
7/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.1%
8/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
11/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.6%
13/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.5%
3/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Investigations
Electrocardiogram QT prolonged
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
2.0%
4/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Investigations
Blood glucose increased
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Investigations
Weight increased
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
2.0%
4/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.5%
5/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.8%
2/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.6%
13/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.5%
5/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
17.6%
3/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
3.6%
7/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
4/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
6/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
2.5%
5/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness postural
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
3.0%
6/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.1%
8/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.1%
1/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Product Issues
Device stimulation issue
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Psychiatric disorders
Insomnia
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.5%
3/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
3/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
3.0%
6/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.1%
1/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.8%
2/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Renal impairment
|
1.0%
2/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
3.6%
7/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
8/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
3.6%
7/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.1%
1/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
8/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.8%
1/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.51%
1/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
11.1%
1/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.51%
1/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
1.0%
2/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
20.0%
1/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
5.9%
1/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Vascular disorders
Hypotension
|
5.6%
11/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
9.5%
2/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
4.6%
9/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/198 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/21 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/17 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/197 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/5 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/9 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
1/8 • Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER