Trial Outcomes & Findings for An Efficacy and Safety Trial of Verubecestat (MK-8931) in Mild to Moderate Alzheimer's Disease (P07738) (NCT NCT01739348)
NCT ID: NCT01739348
Last Updated: 2018-10-24
Results Overview
Least squares mean change from baseline at week 78 was assessed for the ADAS-Cog score. ADAS-Cog measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog score.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
2211 participants
Primary outcome timeframe
Baseline and week 78
Results posted on
2018-10-24
Participant Flow
Part I began by enrolling approximately 50 participants per arm (200 total). Enrollment continued until the first 200 participants reached 13 weeks treatment; total enrollment at that time: \~400. For these \~400 participants (Safety Cohort), an interim analysis (IA) was conducted to assess safety. Following IA, enrollment continued (Main Cohort).
2211 participants were randomized in Part I, with 2210 receiving treatment. As planned per protocol, no participants were randomized to the Verubecestat 60 mg arm (Arm C) in the Main Cohort. Participants completing Part I were eligible to continue to Part II. The trial was terminated early and did not complete as planned.
Participant milestones
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
Part I (Base Study)
STARTED
|
703
|
700
|
103
|
705
|
|
Part I (Base Study)
Treated
|
702
|
700
|
103
|
705
|
|
Part I (Base Study)
COMPLETED
|
501
|
497
|
77
|
516
|
|
Part I (Base Study)
NOT COMPLETED
|
202
|
203
|
26
|
189
|
|
Part II (Extension Study)
STARTED
|
379
|
366
|
61
|
396
|
|
Part II (Extension Study)
Treated
|
379
|
365
|
61
|
394
|
|
Part II (Extension Study)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Part II (Extension Study)
NOT COMPLETED
|
379
|
366
|
61
|
396
|
Reasons for withdrawal
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
Part I (Base Study)
Adverse Event
|
41
|
52
|
8
|
33
|
|
Part I (Base Study)
Death
|
10
|
7
|
2
|
8
|
|
Part I (Base Study)
Lack of Efficacy
|
3
|
8
|
0
|
7
|
|
Part I (Base Study)
Lost to Follow-up
|
4
|
2
|
4
|
4
|
|
Part I (Base Study)
Non-Compliance with Study Drug
|
3
|
2
|
0
|
0
|
|
Part I (Base Study)
Physician Decision
|
10
|
7
|
1
|
4
|
|
Part I (Base Study)
Protocol Violation
|
2
|
0
|
1
|
2
|
|
Part I (Base Study)
Screen Failure
|
2
|
0
|
0
|
0
|
|
Part I (Base Study)
Site Discontinued Study Participation
|
1
|
3
|
0
|
0
|
|
Part I (Base Study)
Study Terminated by Sponsor
|
72
|
73
|
0
|
86
|
|
Part I (Base Study)
Participant Moved
|
4
|
3
|
1
|
7
|
|
Part I (Base Study)
Trial Partner/Caregiver Withdrew Consent
|
27
|
25
|
2
|
18
|
|
Part I (Base Study)
Withdrawal by Subject
|
23
|
21
|
7
|
20
|
|
Part II (Extension Study)
Adverse Event
|
10
|
11
|
7
|
26
|
|
Part II (Extension Study)
Death
|
3
|
3
|
2
|
6
|
|
Part II (Extension Study)
Lack of Efficacy
|
1
|
5
|
0
|
1
|
|
Part II (Extension Study)
Lost to Follow-up
|
3
|
4
|
0
|
1
|
|
Part II (Extension Study)
Non-Compliance with Study Drug
|
0
|
0
|
0
|
1
|
|
Part II (Extension Study)
Physician Decision
|
7
|
11
|
6
|
12
|
|
Part II (Extension Study)
Study Terminated by Sponsor
|
329
|
315
|
34
|
323
|
|
Part II (Extension Study)
Participant Moved
|
3
|
3
|
0
|
3
|
|
Part II (Extension Study)
Trial Partner/Caregiver Withdrew Consent
|
18
|
12
|
8
|
16
|
|
Part II (Extension Study)
Withdrawal by Subject
|
5
|
2
|
4
|
7
|
Baseline Characteristics
All randomized participants (Part I) with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (Full Analysis Set \[FAS\] population).
Baseline characteristics by cohort
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=703 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=700 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
n=103 Participants
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=705 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Total
n=2211 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.2 Years
STANDARD_DEVIATION 7.4 • n=703 Participants
|
71.8 Years
STANDARD_DEVIATION 7.6 • n=700 Participants
|
72.3 Years
STANDARD_DEVIATION 7.4 • n=103 Participants
|
72.4 Years
STANDARD_DEVIATION 7.6 • n=705 Participants
|
71.8 Years
STANDARD_DEVIATION 7.5 • n=2211 Participants
|
|
Sex: Female, Male
Female
|
383 Participants
n=703 Participants
|
403 Participants
n=700 Participants
|
56 Participants
n=103 Participants
|
376 Participants
n=705 Participants
|
1218 Participants
n=2211 Participants
|
|
Sex: Female, Male
Male
|
320 Participants
n=703 Participants
|
297 Participants
n=700 Participants
|
47 Participants
n=103 Participants
|
329 Participants
n=705 Participants
|
993 Participants
n=2211 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=703 Participants
|
3 Participants
n=700 Participants
|
0 Participants
n=103 Participants
|
3 Participants
n=705 Participants
|
7 Participants
n=2211 Participants
|
|
Race (NIH/OMB)
Asian
|
118 Participants
n=703 Participants
|
125 Participants
n=700 Participants
|
11 Participants
n=103 Participants
|
115 Participants
n=705 Participants
|
369 Participants
n=2211 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=703 Participants
|
0 Participants
n=700 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=705 Participants
|
0 Participants
n=2211 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=703 Participants
|
13 Participants
n=700 Participants
|
2 Participants
n=103 Participants
|
7 Participants
n=705 Participants
|
30 Participants
n=2211 Participants
|
|
Race (NIH/OMB)
White
|
566 Participants
n=703 Participants
|
547 Participants
n=700 Participants
|
88 Participants
n=103 Participants
|
578 Participants
n=705 Participants
|
1779 Participants
n=2211 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=703 Participants
|
4 Participants
n=700 Participants
|
2 Participants
n=103 Participants
|
0 Participants
n=705 Participants
|
10 Participants
n=2211 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=703 Participants
|
8 Participants
n=700 Participants
|
0 Participants
n=103 Participants
|
2 Participants
n=705 Participants
|
16 Participants
n=2211 Participants
|
|
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score
|
21.4 Score on a Scale
STANDARD_DEVIATION 7.5 • n=681 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (Full Analysis Set \[FAS\] population).
|
21.3 Score on a Scale
STANDARD_DEVIATION 7.6 • n=672 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (Full Analysis Set \[FAS\] population).
|
20.6 Score on a Scale
STANDARD_DEVIATION 6.2 • n=97 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (Full Analysis Set \[FAS\] population).
|
21.7 Score on a Scale
STANDARD_DEVIATION 7.6 • n=694 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (Full Analysis Set \[FAS\] population).
|
21.42 Score on a Scale
STANDARD_DEVIATION 7.49 • n=2144 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (Full Analysis Set \[FAS\] population).
|
|
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score
|
63.0 Score on a Scale
STANDARD_DEVIATION 9.5 • n=677 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for ADCS-ADL subsequent to ≥1 dose of study drug (FAS population).
|
62.9 Score on a Scale
STANDARD_DEVIATION 9.8 • n=668 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for ADCS-ADL subsequent to ≥1 dose of study drug (FAS population).
|
63.5 Score on a Scale
STANDARD_DEVIATION 10.3 • n=98 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for ADCS-ADL subsequent to ≥1 dose of study drug (FAS population).
|
62.1 Score on a Scale
STANDARD_DEVIATION 10.4 • n=686 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for ADCS-ADL subsequent to ≥1 dose of study drug (FAS population).
|
62.74 Score on a Scale
STANDARD_DEVIATION 9.93 • n=2129 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for ADCS-ADL subsequent to ≥1 dose of study drug (FAS population).
|
|
Clinical Dementia Rating Sum of Boxes (CDR-SB) Score
|
5.4 Score on a Scale
STANDARD_DEVIATION 2.1 • n=660 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for CDR-SB subsequent to ≥1 dose of study drug (FAS population).
|
5.3 Score on a Scale
STANDARD_DEVIATION 2.1 • n=643 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for CDR-SB subsequent to ≥1 dose of study drug (FAS population).
|
5.5 Score on a Scale
STANDARD_DEVIATION 2.3 • n=91 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for CDR-SB subsequent to ≥1 dose of study drug (FAS population).
|
5.6 Score on a Scale
STANDARD_DEVIATION 2.3 • n=673 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for CDR-SB subsequent to ≥1 dose of study drug (FAS population).
|
5.43 Score on a Scale
STANDARD_DEVIATION 2.17 • n=2067 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for CDR-SB subsequent to ≥1 dose of study drug (FAS population).
|
|
Total Hippocampal Volume
|
5894.1 Microliters
STANDARD_DEVIATION 1231.5 • n=332 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for THV subsequent to ≥1 dose of study drug (FAS population).
|
5823.4 Microliters
STANDARD_DEVIATION 1189.9 • n=307 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for THV subsequent to ≥1 dose of study drug (FAS population).
|
5653.5 Microliters
STANDARD_DEVIATION 1148.4 • n=55 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for THV subsequent to ≥1 dose of study drug (FAS population).
|
5800.7 Microliters
STANDARD_DEVIATION 1069.2 • n=346 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for THV subsequent to ≥1 dose of study drug (FAS population).
|
5829.4 Microliters
STANDARD_DEVIATION 1162.6 • n=1040 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for THV subsequent to ≥1 dose of study drug (FAS population).
|
|
Cerebrospinal Fluid (CSF) Total Tau Concentration
|
206.7 picograms (pg)/mL
STANDARD_DEVIATION 90.4 • n=38 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for CSF Total Tau subsequent to ≥1 dose of study drug (FAS population). Per protocol, CSF Total Tau concentration was analyzed as part of a substudy in Part I, with testing occurring at select trial sites.
|
231.5 picograms (pg)/mL
STANDARD_DEVIATION 113.9 • n=57 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for CSF Total Tau subsequent to ≥1 dose of study drug (FAS population). Per protocol, CSF Total Tau concentration was analyzed as part of a substudy in Part I, with testing occurring at select trial sites.
|
268.6 picograms (pg)/mL
STANDARD_DEVIATION 136.2 • n=12 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for CSF Total Tau subsequent to ≥1 dose of study drug (FAS population). Per protocol, CSF Total Tau concentration was analyzed as part of a substudy in Part I, with testing occurring at select trial sites.
|
246.2 picograms (pg)/mL
STANDARD_DEVIATION 192.9 • n=41 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for CSF Total Tau subsequent to ≥1 dose of study drug (FAS population). Per protocol, CSF Total Tau concentration was analyzed as part of a substudy in Part I, with testing occurring at select trial sites.
|
232.2 picograms (pg)/mL
STANDARD_DEVIATION 137.3 • n=148 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window observation for CSF Total Tau subsequent to ≥1 dose of study drug (FAS population). Per protocol, CSF Total Tau concentration was analyzed as part of a substudy in Part I, with testing occurring at select trial sites.
|
|
[18F]Flutemetamol Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVR)
|
0.89 SUVR
STANDARD_DEVIATION 0.10 • n=20 Participants • All randomized participants with a baseline and ≥1 within-analysis-window SUVR observation subsequent to ≥1 dose of study drug (FAS population). SUVR testing occurred at select sites as a Part I substudy. Per protocol, SUVR was not analyzed for the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat.
|
0.87 SUVR
STANDARD_DEVIATION 0.11 • n=10 Participants • All randomized participants with a baseline and ≥1 within-analysis-window SUVR observation subsequent to ≥1 dose of study drug (FAS population). SUVR testing occurred at select sites as a Part I substudy. Per protocol, SUVR was not analyzed for the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat.
|
—
|
0.88 SUVR
STANDARD_DEVIATION 0.11 • n=14 Participants • All randomized participants with a baseline and ≥1 within-analysis-window SUVR observation subsequent to ≥1 dose of study drug (FAS population). SUVR testing occurred at select sites as a Part I substudy. Per protocol, SUVR was not analyzed for the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat.
|
0.88 SUVR
STANDARD_DEVIATION 0.10 • n=44 Participants • All randomized participants with a baseline and ≥1 within-analysis-window SUVR observation subsequent to ≥1 dose of study drug (FAS population). SUVR testing occurred at select sites as a Part I substudy. Per protocol, SUVR was not analyzed for the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat.
|
|
Neuropsychiatric Inventory (NPI) Score
|
8.7 Score on a Scale
STANDARD_DEVIATION 10.5 • n=682 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window NPI observation subsequent to ≥1 dose of study drug (FAS population).
|
8.2 Score on a Scale
STANDARD_DEVIATION 9.8 • n=679 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window NPI observation subsequent to ≥1 dose of study drug (FAS population).
|
6.9 Score on a Scale
STANDARD_DEVIATION 9.5 • n=100 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window NPI observation subsequent to ≥1 dose of study drug (FAS population).
|
9.2 Score on a Scale
STANDARD_DEVIATION 11.6 • n=691 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window NPI observation subsequent to ≥1 dose of study drug (FAS population).
|
8.64 Score on a Scale
STANDARD_DEVIATION 10.6 • n=2152 Participants • All randomized participants (Part I) with a baseline and ≥1 within-analysis-window NPI observation subsequent to ≥1 dose of study drug (FAS population).
|
|
Mini-Mental State Examination (MMSE) Score
|
20.4 Score on a Scale
STANDARD_DEVIATION 3.3 • n=660 Participants • All randomized participants (Part I) with a baseline and ≥1within-analysis-window MMSE observation subsequent to ≥1 dose of study drug (FAS population).
|
20.2 Score on a Scale
STANDARD_DEVIATION 3.3 • n=648 Participants • All randomized participants (Part I) with a baseline and ≥1within-analysis-window MMSE observation subsequent to ≥1 dose of study drug (FAS population).
|
20.6 Score on a Scale
STANDARD_DEVIATION 3.3 • n=98 Participants • All randomized participants (Part I) with a baseline and ≥1within-analysis-window MMSE observation subsequent to ≥1 dose of study drug (FAS population).
|
20.3 Score on a Scale
STANDARD_DEVIATION 3.2 • n=679 Participants • All randomized participants (Part I) with a baseline and ≥1within-analysis-window MMSE observation subsequent to ≥1 dose of study drug (FAS population).
|
20.3 Score on a Scale
STANDARD_DEVIATION 3.3 • n=2085 Participants • All randomized participants (Part I) with a baseline and ≥1within-analysis-window MMSE observation subsequent to ≥1 dose of study drug (FAS population).
|
PRIMARY outcome
Timeframe: Baseline and week 78Population: All randomized participants with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.
Least squares mean change from baseline at week 78 was assessed for the ADAS-Cog score. ADAS-Cog measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog score.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=631 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=626 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=644 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score
|
7.9 Score on a Scale
Interval 7.2 to 8.6
|
8.0 Score on a Scale
Interval 7.3 to 8.7
|
—
|
7.7 Score on a Scale
Interval 7.0 to 8.4
|
PRIMARY outcome
Timeframe: Baseline and week 78Population: All randomized participants with a baseline and ≥1 within-analysis-window ADCS-ADL observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.
Least squares mean change from baseline at week 78 was assessed for the ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=627 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=622 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=636 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score
|
-8.4 Score on a Scale
Interval -9.5 to -7.4
|
-8.2 Score on a Scale
Interval -9.2 to -7.1
|
—
|
-8.9 Score on a Scale
Interval -9.9 to -8.0
|
PRIMARY outcome
Timeframe: Baseline and week 104Population: All randomized participants continuing to Part II, with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (FAS population), having an ADAS-Cog observation at week 104. Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat were excluded.
Mean change from baseline at week 104 was assessed for the ADAS-Cog score. ADAS-Cog measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog score. Per study protocol, the baseline measurement to be used was the baseline measurement obtained in Part I.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=207 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=208 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=216 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part II (Extension Study)] Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score
|
10.1 Score on a Scale
Standard Deviation 9.9
|
8.5 Score on a Scale
Standard Deviation 9.5
|
—
|
9.6 Score on a Scale
Standard Deviation 9.5
|
PRIMARY outcome
Timeframe: Baseline and week 104Population: All randomized participants continuing to Part II, with a baseline and ≥1 within-analysis-window ADCS-ADL observation subsequent to ≥1 dose of study drug (FAS population), having an ADCS-ADL observation at week 104. Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat were excluded.
Mean change from baseline at week 104 was assessed for the ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score. Per study protocol, the baseline measurement to be used was the baseline measurement obtained in Part I.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=207 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=209 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=216 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part II (Extension Study)] Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score
|
-10.7 Score on a Scale
Standard Deviation 13.7
|
-9.2 Score on a Scale
Standard Deviation 12.7
|
—
|
-9.3 Score on a Scale
Standard Deviation 12.0
|
PRIMARY outcome
Timeframe: Up to week 80 (up to 2 weeks following cessation of study treatment in Part I)Population: Includes all randomized participants in Part I receiving ≥1 dose of trial treatment.
The number of participants experiencing an adverse event (AE) in Part I was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=702 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=700 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
n=103 Participants
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=705 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Number of Participants Who Experienced an Adverse Event
|
630 Participants
|
646 Participants
|
90 Participants
|
579 Participants
|
PRIMARY outcome
Timeframe: From week 78 (end of treatment in Part I) up to week 262 of Part IIPopulation: Includes all randomized participants continuing to Part II, receiving ≥1 dose of trial treatment in Part II. For included participants, the data reflect AEs occurring in Part II only.
The number of participants experiencing an adverse event (AE) in Part II was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=379 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=365 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
n=61 Participants
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=394 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part II (Extension Study)] Number of Participants Who Experienced an Adverse Event
|
240 Participants
|
230 Participants
|
51 Participants
|
264 Participants
|
PRIMARY outcome
Timeframe: Up to week 78Population: Includes all randomized participants in Part I receiving ≥1 dose of trial treatment.
The number of participants discontinuing from study drug due to an AE in Part I was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=702 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=700 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
n=103 Participants
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=705 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Number of Participants Who Discontinued From Study Drug Due to an Adverse Event
|
57 Participants
|
64 Participants
|
12 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: From week 78 (end of treatment in Part I) up to week 260 of Part IIPopulation: Includes all randomized participants continuing to Part II, receiving ≥1 dose of trial treatment in Part II. For included participants, the data reflect treatment discontinuations occurring in Part II only.
The number of participants discontinuing from study drug due to an AE in Part II was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=379 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=365 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
n=61 Participants
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=394 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part II (Extension Study)] Number of Participants Who Discontinued From Study Drug Due to an Adverse Event
|
10 Participants
|
9 Participants
|
6 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 78Population: All randomized participants with a baseline and ≥1 within-analysis-window CDR-SB observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.
Least squares mean change from baseline at week 78 was assessed for CDR-SB score. The CDR-SB score is a clinical rating of global cognitive function, comprised of 6 domains including: memory; orientation; judgment and problem solving; community affairs; home and hobbies; and personal care. For each domain, the degree of impairment is assessed by a semi-structured interview of the participant as well as the participant's caregiver. For each domain, potential scores range from 0 (no impairment) to 3 (severe impairment). Scores from each individual domain are summed to the total CDR-SB score, with total scores ranging from 0-18. Higher scores indicate more severe cognitive impairment. Further, increases in cognitive impairment would be reflected by increases in CDR-SB score.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=611 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=600 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=623 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score
|
2.1 Score on a Scale
Interval 1.8 to 2.3
|
2.1 Score on a Scale
Interval 1.9 to 2.4
|
—
|
2.1 Score on a Scale
Interval 1.9 to 2.3
|
SECONDARY outcome
Timeframe: Baseline and week 78Population: All randomized participants with a baseline and ≥1 within-analysis-window THV observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.
Least squares mean percent change from baseline at week 78 was calculated for Total Hippocampal Volume (THV) as measured by volumetric magnetic resonance imaging (vMRI). Longitudinal analysis of within-participant THV is computed using a change analysis algorithm using tensor-based morphometry. This technique produces one measure of volume change calculated from the registration of serial vMRI scans at the follow-up time point relative to baseline. Negative percent changes from baseline indicate decreases in THV (i.e. increased hippocampal atrophy).
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=308 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=281 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=308 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Percent Change From Baseline in Total Hippocampal Volume (THV)
|
-5.6 Percent Change
Interval -5.9 to -5.4
|
-5.7 Percent Change
Interval -5.9 to -5.4
|
—
|
-5.0 Percent Change
Interval -5.2 to -4.7
|
SECONDARY outcome
Timeframe: Baseline and week 78Population: All randomized participants with a baseline and ≥1 within-analysis-window CSF Total Tau observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.
Least squares mean fold change from baseline at week 78 was calculated for Total Tau concentration in CSF, a measure of brain tau pathology. Per protocol, CSF Total Tau concentration was analyzed as part of a substudy in Part I, with testing occurring only at select trial sites. Least squares mean fold change from baseline \>1 indicates increased Total Tau concentration in the CSF.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=32 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=46 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=33 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Fold Change From Baseline in Cerebrospinal Fluid (CSF) Total Tau
|
1.02 Fold Change
Interval 0.96 to 1.08
|
1.04 Fold Change
Interval 0.99 to 1.09
|
—
|
1.07 Fold Change
Interval 1.01 to 1.13
|
SECONDARY outcome
Timeframe: Baseline and week 78Population: All randomized participants with a baseline and ≥1 within-analysis-window SUVR observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat did not receive SUVR testing and were excluded.
Least squares mean change from baseline at week 78 was calculated for SUVR, a measure of brain cortical amyloid load. Per protocol, SUVR was analyzed as part of a substudy in Part I, with testing occurring only at select trial sites. Participants receive the PET tracer \[18F\]Flutemetamol (IV). After 90 minutes, participants receive 4 PET scans (5 minutes each in duration). Using these PET scan images, specific brain ROIs (frontal, temporal, and parietal lobes; anterior and posterior cingulate and precuneus) are used to calculate regional SUVRs, defined as the relative ratio of pixel intensities at a specific ROI compared to a reference region (RR; subcortical white matter). These regional SUVRs are then averaged to compute a composite cortical SUVR for each participant. Higher composite cortical SUVR values indicate increased amyloid load, with negative changes in composite cortical SUVR over time indicating decreases in brain amyloid load.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=20 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=10 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=14 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Change From Baseline in Cortical Amyloid Load Assessed by [18F]Flutemetamol PET Standard Uptake Value Ratio (SUVR)
|
-0.02 SUVR
Interval -0.04 to -0.01
|
-0.04 SUVR
Interval -0.06 to -0.03
|
—
|
0.00 SUVR
Interval -0.01 to 0.01
|
SECONDARY outcome
Timeframe: Week 78Population: All randomized participants in Part I receiving ≥1 dose of trial treatment. Per protocol, the first 200 participants enrolled prior to IA (across all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded from analysis.
The percentage of participants achieving responder status at week 78 was assessed. To determine which participants were considered responders, a linear regression was conducted at the participant level, yielding an estimated 78-week rate of change (i.e., a slope) for each participant with respect to ADAS-Cog and ADCS-ADL. To be declared a responder, a participant must have: 1) ADAS-Cog and ADCS-ADL observations at baseline and 78 weeks of treatment; 2) an ADAS-Cog slope \> 4.0 over 78 weeks, and 3) an ADCS-ADL slope \> -6.3 over 78 weeks. A participant failing to meet any of these criteria was designated as a non-responder at Week 78.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=652 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=652 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=653 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Percentage of Participants Achieving Responder Status
|
20.1 Percentage of Participants
|
19.6 Percentage of Participants
|
—
|
19.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and week 78Population: All randomized participants with a baseline and ≥1 within-analysis-window NPI observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.
Least squares mean change from baseline at week 78 was assessed for NPI score. NPI is a clinical assessment of psychiatric status, covering 12 domains: delusion; hallucination; agitation/aggression; depression/dysphoria; anxiety; elation/euphoria; apathy/indifference; disinhibition; irritability/lability; aberrant motor behavior; sleep/nighttime behaviors; and appetite/eating disorders. Based on an interview of the participant's caregiver, each domain is assessed for symptom frequency \[range: 1 (occasional) to 4 (very frequent)\] and severity \[range: 1 (mild) to 3 (severe)\]. Domain scores \[range: 0 to 12\] are calculated as the product of the frequency and severity scores (i.e. frequency x severity); if no symptoms are present, domain score is 0. The 12 domain scores sum to a total NPI score \[range: 0 (no symptoms in any domain) to 144\]. Higher scores reflect more severe psychiatric impairment, with increases in impairment reflected by increases in NPI score.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=632 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=631 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=639 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Change From Baseline in Neuropsychiatric Inventory (NPI) Score
|
3.4 Score on a Scale
Interval 2.5 to 4.4
|
3.8 Score on a Scale
Interval 2.8 to 4.8
|
—
|
2.7 Score on a Scale
Interval 1.7 to 3.7
|
SECONDARY outcome
Timeframe: Baseline and week 78Population: All randomized participants with a baseline and ≥1 within-analysis-window MMSE observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.
Least squares mean change from baseline at week 78 was assessed for MMSE score. The MMSE is a cognitive assessment of 5 domains including: orientation; attention; memory; language; and constructional praxis. These domains are assessed over the course of 11 total questions related to the participant. Participants are scored based on the number of correct responses; depending on the question, potential scores range from 0 (no correct response) to either 1 (4 questions), 2 (1 question), 3 (3 questions), or 5 (3 questions). Scores from each question are summed to the total MMSE score, with total scores ranging from 0-30. Higher scores indicate better cognitive performance. Further, deterioration in cognitive performance would be reflected by decreases in MMSE score.
Outcome measures
| Measure |
Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]
n=610 Participants
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]
n=600 Participants
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]
n=628 Participants
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study). \[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|
|
[Part I (Base Study)] Change From Baseline in Mini-Mental State Examination (MMSE) Score
|
-3.9 Score on a Scale
Interval -4.3 to -3.6
|
-3.6 Score on a Scale
Interval -4.0 to -3.3
|
—
|
-4.1 Score on a Scale
Interval -4.5 to -3.8
|
Adverse Events
Arm A. Verubecestat 12 mg [Part I]
Serious events: 134 serious events
Other events: 408 other events
Deaths: 9 deaths
Arm B. Verubecestat 40 mg [Part I]
Serious events: 162 serious events
Other events: 440 other events
Deaths: 13 deaths
Arm C. Verubecestat 60mg/40mg [Part I]
Serious events: 24 serious events
Other events: 66 other events
Deaths: 3 deaths
Arm D. Placebo [Part I]
Serious events: 121 serious events
Other events: 337 other events
Deaths: 6 deaths
Arm A. Verubecestat 12 mg [Part II]
Serious events: 57 serious events
Other events: 135 other events
Deaths: 6 deaths
Arm B. Verubecestat 40 mg [Part II]
Serious events: 56 serious events
Other events: 102 other events
Deaths: 4 deaths
Arm C. Verubecestat 40 mg [Part II]
Serious events: 22 serious events
Other events: 37 other events
Deaths: 4 deaths
Arm D. Verubecestat 40 mg [Part II]
Serious events: 69 serious events
Other events: 144 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm A. Verubecestat 12 mg [Part I]
n=702 participants at risk
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study).
|
Arm B. Verubecestat 40 mg [Part I]
n=700 participants at risk
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study).
|
Arm C. Verubecestat 60mg/40mg [Part I]
n=103 participants at risk
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks).
|
Arm D. Placebo [Part I]
n=705 participants at risk
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study).
|
Arm A. Verubecestat 12 mg [Part II]
n=379 participants at risk
\[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part II]
n=365 participants at risk
\[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 40 mg [Part II]
n=61 participants at risk
\[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Verubecestat 40 mg [Part II]
n=394 participants at risk
\[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.9%
2/103 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.28%
2/705 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Angina unstable
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Atrial fibrillation
|
0.43%
3/702 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.9%
3/103 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Bradycardia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Cardiac arrest
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.51%
2/394 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Myocardial infarction
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Sinus bradycardia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Torsade de pointes
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Endocrine disorders
Thyroid cyst
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Eye disorders
Cataract
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.28%
2/705 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Eye disorders
Corneal oedema
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Eye disorders
Glaucoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Eye disorders
Keratitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Eye disorders
Macular oedema
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Eye disorders
Trichiasis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.51%
2/394 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Anal prolapse
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.76%
3/394 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Diverticulum
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Diverticulum oesophageal
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Haematemesis
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Nausea
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Asthenia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.28%
2/705 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Chest discomfort
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Chest pain
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.57%
4/700 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Death
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Drowning
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Euthanasia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Gait disturbance
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
General physical health deterioration
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Malaise
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Mass
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.28%
2/705 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Pyrexia
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.76%
3/394 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Bronchitis
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Cystitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.53%
2/379 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Gallbladder empyema
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Haematoma infection
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Neurosyphilis
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Peritonitis
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Pneumonia
|
0.71%
5/702 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.86%
6/700 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.9%
3/103 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.71%
5/705 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.79%
3/379 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.4%
5/365 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
4.9%
3/61 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.0%
4/394 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Retroperitoneal infection
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Sepsis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Urinary tract infection
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.28%
2/705 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.53%
2/379 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Urosepsis
|
0.43%
3/702 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.28%
2/705 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.51%
2/394 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.43%
3/702 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.51%
2/394 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.71%
5/700 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.53%
2/379 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Prescribed overdose
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.53%
2/379 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Ammonia increased
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Blood glucose fluctuation
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Heart rate irregular
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Hepatic enzyme increased
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Lipoprotein (a) increased
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Liver function test increased
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Prostatic specific antigen increased
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.82%
3/365 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Hypokalaemic syndrome
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/700 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Starvation
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/700 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/705 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.51%
2/394 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Atypical fibroxanthoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.3%
9/702 • Number of events 11 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.3%
9/700 • Number of events 14 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.1%
15/705 • Number of events 17 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.53%
2/379 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.82%
3/365 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.51%
2/394 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage II
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Borderline mucinous tumour of ovary
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/705 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extradural neoplasm
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/700 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/705 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/705 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma uterus
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin squamous cell carcinoma metastatic
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.71%
5/702 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/700 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.9%
2/103 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/705 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.3%
5/379 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.43%
3/702 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.57%
4/705 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Amnesia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Cerebral infarction
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.86%
6/700 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.57%
4/705 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Dementia
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.3%
5/394 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Diplegia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Dizziness
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/705 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Epilepsy
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Headache
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Presyncope
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.79%
3/379 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Radiculopathy
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Sciatica
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Seizure
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.55%
2/365 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.76%
3/394 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.28%
2/705 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Syncope
|
1.00%
7/702 • Number of events 7 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.9%
13/700 • Number of events 15 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.71%
5/705 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.82%
3/365 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.51%
2/394 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.43%
3/702 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.28%
2/705 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.28%
2/705 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.51%
2/394 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Agitation
|
0.57%
4/702 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.57%
4/700 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.3%
5/379 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.51%
2/394 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Completed suicide
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.43%
3/705 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.53%
2/379 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.57%
4/700 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.53%
2/379 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Delusional disorder, persecutory type
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Depression
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Mental status changes
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.79%
3/379 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Neuropsychiatric symptoms
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.76%
3/394 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Psychogenic movement disorder
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Psychotic disorder
|
0.14%
1/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Sleep disorder
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Suicidal ideation
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Calculus bladder
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Renal colic
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.28%
2/702 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.43%
3/702 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Noninfective bronchitis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal pouch
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.51%
2/394 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Vascular disorders
Aortic stenosis
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Vascular disorders
Arteriosclerosis
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Vascular disorders
Hypotension
|
0.14%
1/702 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/700 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.29%
2/700 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/705 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.25%
1/394 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/702 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/700 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/103 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.14%
1/705 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/379 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/394 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
Other adverse events
| Measure |
Arm A. Verubecestat 12 mg [Part I]
n=702 participants at risk
\[Part I\] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study).
|
Arm B. Verubecestat 40 mg [Part I]
n=700 participants at risk
\[Part I\] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study).
|
Arm C. Verubecestat 60mg/40mg [Part I]
n=103 participants at risk
\[Part I\] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks).
|
Arm D. Placebo [Part I]
n=705 participants at risk
\[Part I\] Placebo once daily for 78 weeks in Study Part I (Base Study).
|
Arm A. Verubecestat 12 mg [Part II]
n=379 participants at risk
\[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
|
Arm B. Verubecestat 40 mg [Part II]
n=365 participants at risk
\[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm C. Verubecestat 40 mg [Part II]
n=61 participants at risk
\[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
Arm D. Verubecestat 40 mg [Part II]
n=394 participants at risk
\[Part II\] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
8/702 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
11/700 • Number of events 11 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.97%
1/103 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.85%
6/705 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.3%
5/379 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.6%
4/61 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.3%
5/394 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
30/702 • Number of events 32 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.9%
27/700 • Number of events 29 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
8.7%
9/103 • Number of events 9 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.8%
20/705 • Number of events 20 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.4%
13/379 • Number of events 14 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.82%
3/365 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.6%
4/61 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.5%
10/394 • Number of events 10 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
56/702 • Number of events 65 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
8.6%
60/700 • Number of events 70 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.9%
4/103 • Number of events 9 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.0%
42/705 • Number of events 45 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.1%
8/379 • Number of events 9 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.2%
8/365 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.6%
4/61 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.3%
9/394 • Number of events 10 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Bronchitis
|
3.4%
24/702 • Number of events 28 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.4%
10/700 • Number of events 11 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.8%
6/103 • Number of events 7 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.7%
19/705 • Number of events 19 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.4%
9/379 • Number of events 12 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.4%
5/365 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.0%
4/394 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Urinary tract infection
|
8.7%
61/702 • Number of events 79 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
10.1%
71/700 • Number of events 93 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
14.6%
15/103 • Number of events 18 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
7.9%
56/705 • Number of events 68 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.3%
20/379 • Number of events 25 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
4.9%
18/365 • Number of events 21 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
8.2%
5/61 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
7.1%
28/394 • Number of events 34 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.5%
60/702 • Number of events 81 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
7.1%
50/700 • Number of events 60 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
4.9%
5/103 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.0%
42/705 • Number of events 49 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.5%
21/379 • Number of events 27 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.0%
11/365 • Number of events 12 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.5%
10/394 • Number of events 11 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.6%
25/702 • Number of events 31 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
4.3%
30/700 • Number of events 33 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.8%
7/103 • Number of events 9 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.0%
21/705 • Number of events 27 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.7%
14/379 • Number of events 21 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.2%
8/365 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.3%
5/394 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
56/702 • Number of events 84 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
8.4%
59/700 • Number of events 75 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
7.8%
8/103 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.5%
39/705 • Number of events 51 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
8.2%
31/379 • Number of events 37 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.2%
19/365 • Number of events 25 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
11.5%
7/61 • Number of events 14 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.6%
22/394 • Number of events 27 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Investigations
Weight decreased
|
6.7%
47/702 • Number of events 48 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.3%
44/700 • Number of events 44 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.8%
7/103 • Number of events 7 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.0%
21/705 • Number of events 22 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.6%
10/379 • Number of events 10 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.2%
8/365 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
13/394 • Number of events 13 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.7%
19/702 • Number of events 20 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
4.3%
30/700 • Number of events 31 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.8%
6/103 • Number of events 7 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.3%
16/705 • Number of events 16 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.1%
4/379 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/365 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.5%
10/394 • Number of events 10 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
36/702 • Number of events 41 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.7%
26/700 • Number of events 26 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.9%
4/103 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.0%
21/705 • Number of events 23 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.1%
8/379 • Number of events 11 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.9%
7/365 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
8.2%
5/61 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.76%
3/394 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
36/702 • Number of events 39 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.6%
46/700 • Number of events 49 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.8%
6/103 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
4.3%
30/705 • Number of events 34 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.1%
8/379 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.9%
7/365 • Number of events 7 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.5%
6/394 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Dizziness
|
4.7%
33/702 • Number of events 34 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
8.0%
56/700 • Number of events 70 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
11.7%
12/103 • Number of events 15 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
4.5%
32/705 • Number of events 35 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.4%
9/379 • Number of events 9 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.82%
3/365 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.0%
8/394 • Number of events 10 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Nervous system disorders
Headache
|
6.0%
42/702 • Number of events 48 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
7.4%
52/700 • Number of events 59 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
4.9%
5/103 • Number of events 7 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.8%
41/705 • Number of events 58 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.1%
4/379 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.4%
5/365 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.5%
6/394 • Number of events 9 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Abnormal dreams
|
1.6%
11/702 • Number of events 11 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.1%
15/700 • Number of events 16 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.8%
6/103 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.85%
6/705 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.26%
1/379 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.27%
1/365 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.00%
0/61 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.76%
3/394 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Agitation
|
4.4%
31/702 • Number of events 32 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.3%
16/700 • Number of events 17 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
4.9%
5/103 • Number of events 7 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.7%
19/705 • Number of events 20 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.1%
8/379 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.4%
5/365 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
8.2%
5/61 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.5%
10/394 • Number of events 11 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Anxiety
|
5.7%
40/702 • Number of events 41 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.7%
47/700 • Number of events 51 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
7.8%
8/103 • Number of events 10 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.8%
27/705 • Number of events 29 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
6/379 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
6/365 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
9.8%
6/61 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.0%
8/394 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Depression
|
6.7%
47/702 • Number of events 52 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.6%
46/700 • Number of events 48 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
8.7%
9/103 • Number of events 9 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.4%
38/705 • Number of events 38 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.3%
5/379 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
6/365 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
8.2%
5/61 • Number of events 5 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.0%
8/394 • Number of events 9 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Insomnia
|
5.8%
41/702 • Number of events 42 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
4.7%
33/700 • Number of events 33 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.8%
6/103 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.0%
21/705 • Number of events 23 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.2%
12/379 • Number of events 12 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.2%
8/365 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.5%
10/394 • Number of events 10 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Psychiatric disorders
Suicidal ideation
|
5.6%
39/702 • Number of events 42 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
6.4%
45/700 • Number of events 55 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.9%
4/103 • Number of events 4 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.4%
24/705 • Number of events 26 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.2%
12/379 • Number of events 14 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.5%
9/365 • Number of events 9 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
2/61 • Number of events 2 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.0%
12/394 • Number of events 13 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
32/702 • Number of events 38 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.7%
26/700 • Number of events 27 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.8%
6/103 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.1%
22/705 • Number of events 23 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.8%
7/379 • Number of events 9 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.5%
9/365 • Number of events 10 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.3%
13/394 • Number of events 14 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
33/702 • Number of events 38 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.7%
26/700 • Number of events 31 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
5.8%
6/103 • Number of events 6 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
3.5%
25/705 • Number of events 31 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.8%
7/379 • Number of events 7 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
0.82%
3/365 • Number of events 3 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
1.6%
1/61 • Number of events 1 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
2.0%
8/394 • Number of events 8 • [Part I]: Up to week 80 of Part I (up to 2 weeks following cessation of study treatment in Part I); [Part II]: From week 78 (end of treatment in Part I) up to week 262 of Study Part II
\[Part I\] Includes all randomized participants in Study Part I (Base Study) receiving ≥1 dose of trial treatment. \[Part II\] Includes all randomized participants continuing to Study Part II (Extension Study) receiving ≥1 dose of trial treatment in Part II. For Part II-specific arms, only the AEs occurring during study Part II are reported.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor, 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
- Publication restrictions are in place
Restriction type: OTHER