Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (NCT NCT04242446)
NCT ID: NCT04242446
Last Updated: 2025-11-06
Results Overview
HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an adverse event (AE) or lack of efficacy. Percentage of participants shown do not account for model effects using the logistic regression model.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
505 participants
Primary outcome timeframe
Week 16
Results posted on
2025-11-06
Participant Flow
The study started to enroll participants in February 2020 and concluded in February 2023.
Participant Flow refers to the Randomized Set (RS) and Maintenance Set (MS).
Participant milestones
| Measure |
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Initial Treatment Period: Week 0-16
STARTED
|
72
|
144
|
289
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
COMPLETED
|
65
|
127
|
259
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
NOT COMPLETED
|
7
|
17
|
30
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
STARTED
|
0
|
0
|
0
|
65
|
125
|
129
|
129
|
|
Maintenance Treatment Period: Week 16-48
COMPLETED
|
0
|
0
|
0
|
44
|
87
|
104
|
98
|
|
Maintenance Treatment Period: Week 16-48
NOT COMPLETED
|
0
|
0
|
0
|
21
|
38
|
25
|
31
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Initial Treatment Period: Week 0-16
Adverse Event
|
1
|
5
|
7
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Protocol Violation
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Lost to Follow-up
|
1
|
3
|
2
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Consent withdrawn by subject, not due to AE
|
4
|
6
|
14
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Country Relocation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Withdrawn based to Exclusion Criterion
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Per Sponsors Request Due To Covid 19 Pandemic
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Randomized, not treated
|
0
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
Adverse Event
|
0
|
0
|
0
|
9
|
7
|
5
|
6
|
|
Maintenance Treatment Period: Week 16-48
Lack of Efficacy
|
0
|
0
|
0
|
1
|
7
|
3
|
3
|
|
Maintenance Treatment Period: Week 16-48
Protocol Violation
|
0
|
0
|
0
|
1
|
2
|
1
|
2
|
|
Maintenance Treatment Period: Week 16-48
Lost to Follow-up
|
0
|
0
|
0
|
2
|
5
|
3
|
3
|
|
Maintenance Treatment Period: Week 16-48
Consent withdrawn by subject, not due to AE
|
0
|
0
|
0
|
7
|
12
|
11
|
14
|
|
Maintenance Treatment Period: Week 16-48
Subject Is Moving A Long Distance From Clinic
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
Study Schedule Too Demanding, Clashing With Work
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
Subject Moved A Long Distance From Clinic
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
Subject Withdrew Due To Custody Issue & Relocation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
Relocation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
Patient Relocated And Withdrew Consent
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
Patient Move Away
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Maintenance Treatment Period: Week 16-48
Patient Relocated Last Minute Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Maintenance Treatment Period: Week 16-48
Needs Systemic Therapy Incompatible With Protocol
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Maintenance Treatment Period: Week 16-48
Sponsor's Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Maintenance Treatment Period: Week 16-48
Develop Illness Would Interfere With Participation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=289 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Total
n=505 Participants
Total of all reporting groups
|
Placebo
n=72 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|
|
Age, Continuous
|
36.3 Years
STANDARD_DEVIATION 11.2 • n=50 Participants
|
36.9 Years
STANDARD_DEVIATION 12.4 • n=50 Participants
|
36.7 Years
STANDARD_DEVIATION 12.0 • n=50 Participants
|
36.4 Years
STANDARD_DEVIATION 12.4 • n=49 Participants
|
|
Age, Customized
18 years - <65 years
|
143 Participants
n=50 Participants
|
283 Participants
n=50 Participants
|
497 Participants
n=50 Participants
|
71 Participants
n=49 Participants
|
|
Age, Customized
65 years - <85 years
|
1 Participants
n=50 Participants
|
6 Participants
n=50 Participants
|
8 Participants
n=50 Participants
|
1 Participants
n=49 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=50 Participants
|
176 Participants
n=50 Participants
|
318 Participants
n=50 Participants
|
44 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=50 Participants
|
113 Participants
n=50 Participants
|
187 Participants
n=50 Participants
|
28 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
8 Participants
n=50 Participants
|
3 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 Participants
n=50 Participants
|
41 Participants
n=50 Participants
|
70 Participants
n=50 Participants
|
8 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
White
|
105 Participants
n=50 Participants
|
233 Participants
n=50 Participants
|
393 Participants
n=50 Participants
|
55 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Other/mixed
|
13 Participants
n=50 Participants
|
10 Participants
n=50 Participants
|
28 Participants
n=50 Participants
|
5 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
1 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 Participants
n=50 Participants
|
20 Participants
n=50 Participants
|
37 Participants
n=50 Participants
|
4 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
131 Participants
n=50 Participants
|
268 Participants
n=50 Participants
|
466 Participants
n=50 Participants
|
67 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The RS consisted of all participants randomized into the study.
HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an adverse event (AE) or lack of efficacy. Percentage of participants shown do not account for model effects using the logistic regression model.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=289 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
|
28.7 percentage of participants
Interval 18.1 to 39.3
|
45.3 percentage of participants
Interval 36.8 to 53.8
|
47.8 percentage of participants
Interval 41.8 to 53.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The RS consisted of all participants randomized into the study.
HiSCR75 was defined as at least a 75% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an AE or lack of efficacy. Percentage of participants shown do not account for model effects using the logistic regression model.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=289 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16
|
18.4 percentage of participants
Interval 9.3 to 27.5
|
24.7 percentage of participants
Interval 17.3 to 32.1
|
33.4 percentage of participants
Interval 27.8 to 39.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The RS consisted of all study participants randomized into the study. Mean values shown do not account for model effects using the analysis of covariance (ANCOVA) model. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy.
The DLQI is a patient-reported questionnaire designed for use in adult participants with skin diseases and Hidradenitis Suppurativa (HS). The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL), with a recall period of 7 days. This instrument asks participants 10 questions about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The scoring of each answer for the DLQI is on a scale range of 0 (not at all) to 3 (very much). The DLQI total score was calculated by adding the score of each question. The maximum score is 30, and the minimum score is 0. The higher the score, the more quality of life is impaired. Participants who experienced an intercurrent event were treated as missing following the intercurrent event and imputed using the multiple imputation method for missing data.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=289 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
|
-2.7 score on a scale
Standard Error 0.9
|
-5.5 score on a scale
Standard Error 0.6
|
-5.0 score on a scale
Standard Error 0.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The RS consisted of all study participants randomized into the study. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy.
Absolute change from Baseline in Worst Skin Pain score at Week 16 was assessed using the worst skin pain item in the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD). Worst skin pain during the past 24 hours was assessed daily using an 11-point numeric rating scale (NRS) which ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The worst skin pain score was derived from the weekly average of daily scores, defined as the sum of the scored item over the course of the study week divided by the number of days in which the item was completed, relative to each respective visit date. Intermittent missing data are imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Participants who experienced an intercurrent event were treated as missing following the intercurrent event and imputed using the multiple imputation method for missing data. Mean values shown do not account for model effects using the ANCOVA model.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=289 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Worst Skin Pain Score at Week 16
|
-0.99 score on a scale
Standard Error 0.38
|
-1.56 score on a scale
Standard Error 0.26
|
-2.00 score on a scale
Standard Error 0.17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The RS consisted of all study participants randomized into the study. Here, number of participants analyzed included RS with HSSDD worst skin pain score \>=3 at Baseline. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy.
Skin pain response at Week 16, as assessed by "worst skin pain" item in HSSDD, was defined as an improvement in weekly worst skin pain score of at least 3 points versus Baseline. Worst skin pain during the past 24 hours was assessed daily using an 11-point numeric rating scale (NRS) which ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Worst skin pain score was derived from weekly average of daily scores (sum of scored item over study week/number of days in which item completed, relative to each respective visit). Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Weekly pain scores were imputed and then dichotomized to obtain response status. Participants who experienced an intercurrent event were treated as non-responders following the intercurrent event. Percentage of participants shown do not account for model effects using logistic regression model.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=103 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=190 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Worst Skin Pain Response at Week 16
|
15.0 percentage of participants
Interval 3.6 to 26.5
|
22.1 percentage of participants
Interval 12.7 to 31.4
|
32.3 percentage of participants
Interval 25.1 to 39.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] period).
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=143 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=286 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
n=65 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
n=129 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
n=129 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
n=125 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
|
66.7 percentage of participants
|
65.7 percentage of participants
|
67.1 percentage of participants
|
81.5 percentage of participants
|
79.1 percentage of participants
|
81.4 percentage of participants
|
76.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)Population: The SS consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events. TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period).
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=143 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=286 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
n=65 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
n=129 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
n=129 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
n=125 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study
|
0 percentage of participants
|
2.8 percentage of participants
|
2.1 percentage of participants
|
9.2 percentage of participants
|
5.4 percentage of participants
|
7.8 percentage of participants
|
8.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)Population: The SS consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs leading to discontinuation of the study are reported.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=143 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=286 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
n=65 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
n=129 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
n=129 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
n=125 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study
|
1.4 percentage of participants
|
4.2 percentage of participants
|
3.5 percentage of participants
|
13.8 percentage of participants
|
1.6 percentage of participants
|
4.7 percentage of participants
|
4.8 percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
BKZ Dosing Regimen 1
Serious events: 4 serious events
Other events: 52 other events
Deaths: 0 deaths
BKZ Dosing Regimen 2
Serious events: 6 serious events
Other events: 94 other events
Deaths: 0 deaths
Placebo/BKZ Dosing Regimen 2
Serious events: 6 serious events
Other events: 38 other events
Deaths: 0 deaths
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
Serious events: 10 serious events
Other events: 63 other events
Deaths: 0 deaths
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
Serious events: 7 serious events
Other events: 69 other events
Deaths: 0 deaths
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
Serious events: 10 serious events
Other events: 63 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=72 participants at risk
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=143 participants at risk
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=286 participants at risk
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
n=65 participants at risk
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
n=125 participants at risk
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
n=129 participants at risk
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
n=129 participants at risk
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.35%
1/286 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Eye disorders
Keratitis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/143 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/143 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.35%
1/286 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.35%
1/286 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.35%
1/286 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.35%
1/286 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/143 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
1/65 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.80%
1/125 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.35%
1/286 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
1/65 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.4%
3/125 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.6%
2/129 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/143 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
1/65 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.80%
1/125 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
1/65 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
1/65 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.80%
1/125 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.80%
1/125 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Groin infection
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Sepsis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.80%
1/125 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
1/65 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
1/65 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.80%
1/125 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.80%
1/125 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Reproductive system and breast disorders
Genital erythema
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
1/65 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.80%
1/125 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/125 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/286 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.80%
1/125 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/129 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
Other adverse events
| Measure |
Placebo
n=72 participants at risk
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=143 participants at risk
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=286 participants at risk
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
n=65 participants at risk
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
n=125 participants at risk
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
n=129 participants at risk
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
n=129 participants at risk
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.4%
2/143 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.9%
17/286 • Number of events 18 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.6%
3/65 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
8.8%
11/125 • Number of events 12 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
7.8%
10/129 • Number of events 13 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
8.5%
11/129 • Number of events 17 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
6/72 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.4%
7/286 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/65 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.2%
4/125 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.6%
2/129 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Nervous system disorders
Headache
|
4.2%
3/72 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.6%
8/143 • Number of events 14 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
7.7%
22/286 • Number of events 27 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
7.7%
5/65 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.2%
4/125 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.2%
8/129 • Number of events 8 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.9%
5/129 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
13.9%
10/72 • Number of events 11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
8.4%
12/143 • Number of events 15 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.3%
18/286 • Number of events 21 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
16.9%
11/65 • Number of events 13 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
21.6%
27/125 • Number of events 38 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
14.7%
19/129 • Number of events 25 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
13.2%
17/129 • Number of events 32 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Corona virus infection
|
2.8%
2/72 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.4%
2/143 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.1%
9/286 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
13.8%
9/65 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
11.2%
14/125 • Number of events 14 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
14.7%
19/129 • Number of events 20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
14.0%
18/129 • Number of events 18 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Fungal skin infection
|
1.4%
1/72 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.1%
3/143 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
2/286 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.1%
2/65 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.4%
3/125 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.4%
7/129 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.1%
4/129 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/72 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
8.4%
12/143 • Number of events 14 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.3%
18/286 • Number of events 21 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
9.2%
6/65 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.8%
6/125 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.9%
5/129 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.7%
6/129 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Influenza
|
2.8%
2/72 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.0%
3/286 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.2%
4/65 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.6%
2/125 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.6%
2/129 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.6%
2/129 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
3/72 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.9%
7/143 • Number of events 10 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.2%
12/286 • Number of events 14 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.2%
4/65 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.8%
6/125 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
7.8%
10/129 • Number of events 12 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.1%
4/129 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/143 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.4%
4/286 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.1%
2/65 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.6%
7/125 • Number of events 8 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.4%
7/129 • Number of events 8 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.4%
7/129 • Number of events 10 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/72 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.8%
4/143 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.4%
4/286 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.2%
4/65 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.4%
3/125 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
7.0%
9/129 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.2%
8/129 • Number of events 8 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Investigations
Psychiatric evaluation abnormal
|
2.8%
2/72 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.9%
7/143 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
2/286 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.2%
4/65 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.2%
4/125 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.6%
2/129 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
1/72 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.1%
3/143 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.7%
5/286 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.1%
2/65 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.6%
7/125 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.9%
5/129 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.4%
7/129 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/72 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.8%
4/143 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.1%
6/286 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.6%
3/65 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.4%
3/125 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.4%
7/129 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.78%
1/129 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60