Trial Outcomes & Findings for A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (NCT NCT03895203)
NCT ID: NCT03895203
Last Updated: 2026-01-27
Results Overview
ACR50 response rate: 50% or greater improvement of arthritis relative to Baseline. Those who met following 3 conditions for improvement from Baseline were classified as meeting ACR50 response criteria: greater than or equal (≥) 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; ≥ 50% improvement in at least 3 of 5 following parameters: Physician global assessment of disease activity (0-100 millimeter \[mm\] visual analog scale \[VAS\] \[0 = no symptoms;100 = severe symptoms\]), Patient global assessment of disease activity (100 mm VAS \[0 = no limitation of normal activities; 100 = very poor\]), Patient assessment of pain (100 mm VAS \[0 = no pain; 100 = most severe pain\]), Health Assessment Questionnaire-Disability Index (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, lower scores indicated less disability and high-sensitivity C-reactive protein (hsCRP).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
852 participants
Primary outcome timeframe
Week 16
Results posted on
2026-01-27
Participant Flow
The study started to enroll participants in April 2019 and concluded in July 2022.
The Participant Flow refers to the Randomized Set (RS) and Active Treatment-Blind Set (ATS).
Participant milestones
| Measure |
Placebo
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
BKZ 160 mg Q4W
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period: 16 Weeks
STARTED
|
281
|
431
|
140
|
0
|
0
|
0
|
|
Double-Blind Treatment Period: 16 Weeks
Enthesitis at Baseline: PA0010/PA0011 Pooled Population
|
106
|
249
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period: 16 Weeks
Dactylitis at Baseline: PA0010/PA0011 Pooled Population
|
47
|
90
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period: 16 Weeks
COMPLETED
|
271
|
415
|
137
|
0
|
0
|
0
|
|
Double-Blind Treatment Period: 16 Weeks
NOT COMPLETED
|
10
|
16
|
3
|
0
|
0
|
0
|
|
Active Treatment-Blind Period: 36 Weeks
STARTED
|
0
|
0
|
0
|
271
|
414
|
136
|
|
Active Treatment-Blind Period: 36 Weeks
COMPLETED
|
0
|
0
|
0
|
257
|
387
|
125
|
|
Active Treatment-Blind Period: 36 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
14
|
27
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
BKZ 160 mg Q4W
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period: 16 Weeks
Adverse Event
|
2
|
8
|
2
|
0
|
0
|
0
|
|
Double-Blind Treatment Period: 16 Weeks
Lack of Efficacy
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period: 16 Weeks
Lost to Follow-up
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period: 16 Weeks
Withdrawal by Subject
|
4
|
6
|
1
|
0
|
0
|
0
|
|
Double-Blind Treatment Period: 16 Weeks
PHQ-9 Score elevated
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period: 16 Weeks
Site terminated
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Active Treatment-Blind Period: 36 Weeks
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Active Treatment-Blind Period: 36 Weeks
Adverse Event
|
0
|
0
|
0
|
5
|
9
|
4
|
|
Active Treatment-Blind Period: 36 Weeks
Lack of Efficacy
|
0
|
0
|
0
|
1
|
6
|
4
|
|
Active Treatment-Blind Period: 36 Weeks
Lost to Follow-up
|
0
|
0
|
0
|
1
|
3
|
0
|
|
Active Treatment-Blind Period: 36 Weeks
Withdrawal by Subject
|
0
|
0
|
0
|
4
|
9
|
2
|
|
Active Treatment-Blind Period: 36 Weeks
COVID-19 Pandemic Circumstances
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Active Treatment-Blind Period: 36 Weeks
Withdrawal due to Subject Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Active Treatment-Blind Period: 36 Weeks
Subject Moving Out of Area
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Total
n=852 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
255 Participants
n=25 Participants
|
386 Participants
n=25 Participants
|
122 Participants
n=50 Participants
|
763 Participants
n=152 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=25 Participants
|
45 Participants
n=25 Participants
|
18 Participants
n=50 Participants
|
89 Participants
n=152 Participants
|
|
Age, Continuous
|
48.7 Years
STANDARD_DEVIATION 11.7 • n=25 Participants
|
48.5 Years
STANDARD_DEVIATION 12.6 • n=25 Participants
|
49.0 Years
STANDARD_DEVIATION 12.8 • n=50 Participants
|
48.7 Years
STANDARD_DEVIATION 12.3 • n=152 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=25 Participants
|
230 Participants
n=25 Participants
|
69 Participants
n=50 Participants
|
453 Participants
n=152 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=25 Participants
|
201 Participants
n=25 Participants
|
71 Participants
n=50 Participants
|
399 Participants
n=152 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan native
|
0 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=152 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=25 Participants
|
17 Participants
n=25 Participants
|
4 Participants
n=50 Participants
|
28 Participants
n=152 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=152 Participants
|
|
Race/Ethnicity, Customized
White
|
270 Participants
n=25 Participants
|
410 Participants
n=25 Participants
|
133 Participants
n=50 Participants
|
813 Participants
n=152 Participants
|
|
Race/Ethnicity, Customized
Other/mixed
|
4 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
5 Participants
n=152 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=152 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
2 Participants
n=50 Participants
|
11 Participants
n=152 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
276 Participants
n=25 Participants
|
426 Participants
n=25 Participants
|
136 Participants
n=50 Participants
|
838 Participants
n=152 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: RS consisted of all enrolled participants who had been randomized. Participants who had missing ACR50 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not were considered as non-responders. Inferential Statistics for ADA 40 mg reference arm was not calculated and reported as no formal comparison was planned.
ACR50 response rate: 50% or greater improvement of arthritis relative to Baseline. Those who met following 3 conditions for improvement from Baseline were classified as meeting ACR50 response criteria: greater than or equal (≥) 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; ≥ 50% improvement in at least 3 of 5 following parameters: Physician global assessment of disease activity (0-100 millimeter \[mm\] visual analog scale \[VAS\] \[0 = no symptoms;100 = severe symptoms\]), Patient global assessment of disease activity (100 mm VAS \[0 = no limitation of normal activities; 100 = very poor\]), Patient assessment of pain (100 mm VAS \[0 = no pain; 100 = most severe pain\]), Health Assessment Questionnaire-Disability Index (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, lower scores indicated less disability and high-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16
|
43.9 percentage of participants
|
45.7 percentage of participants
|
10.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: RS consisted of all enrolled participants who had been randomized. Missing data and non-missing data preceded by a study treatment discontinuation were imputed using reference based multiple imputation. Descriptive statistics for ADA 40 mg reference arm was not calculated and reported since reference based imputation analysis method is used with Placebo as reference. As pre-specified in the SAP, this analysis was performed only for the participants randomized to Placebo and BKZ.
The HAQ-DI contains 20 items that measured the degree of difficulty experienced in the following 8 categories of the daily living activities: dressing and grooming (2 items), arising (2 items), eating (3 items), walking (2 items), hygiene (3 items), reach (2 items), grip (3 items), and common daily activities (3 items). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). The overall HAQ-DI total score was calculated by dividing the sum of the highest category scores (0 to 24) by the number of categories with at least 1 question answered. The HAQ-DI total score ranges from 0 (no difficulty) to 3 (maximum difficulty). A lower HAQ-DI score indicated an improvement in function. Change from baseline was computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicated an improvement.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 for Placebo and BKZ
|
-0.2567 score on a scale
Standard Error 0.0208
|
—
|
-0.0881 score on a scale
Standard Error 0.0273
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Subset of study participants in RS with psoriasis involving at least 3% BSA at Baseline. Participants who have missing PASI90 data at Week 4 or who discontinued study treatment before Week 4 regardless of whether they had data or not are considered as non-responders.
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI = average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0 = no disease, the maximum score is 72 = maximal disease.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=217 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=68 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=140 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline
|
19.8 percentage of participants
|
7.4 percentage of participants
|
4.3 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Subset of study participants in RS with psoriasis involving at least 3% BSA at Baseline. Participants who have missing PASI90 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they have data or not are considered as non-responders. Inferential Statistics for ADA 40 mg reference arm was not calculated and reported as no formal comparison was planned.
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI = average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0 = no disease, the maximum score is 72 = maximal disease.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=217 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=68 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=140 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% BSA at Baseline
|
61.3 percentage of participants
|
41.2 percentage of participants
|
2.9 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: RS consisted of all enrolled participants who had been randomized. Missing data and non-missing data preceded by a study treatment discontinuation were imputed using reference based multiple imputation. Descriptive statistics for ADA 40 mg reference arm was not calculated and reported since imputation analysis method was used with Placebo as reference. As pre-specified in the SAP, this analysis was performed only for the participants randomized to Placebo and BKZ.
SF-36 (version 2, standard recall):36-item generic health-related Quality of Life instrument that uses recall period of 4 weeks. Questionnaire has 36 questions composing scale that represent 8 domains:physical functioning; role physical; bodily pain;general health;vitality; social functioning;role emotional; and mental health. Scores for 8 domains were combined into two summary scores: physical component summary (PCS) score and mental component summary (MCS) score. Scores for 2 components summary (PCS and MCS) and 8 domains have been calculated and computed as raw/observed score to norm-based T-score metric(mean=50, standard deviation=10), raw score min=0(worst), max=100(best). Individual respondent's score falls outside T-score range of 45 to 55 was considered outside average range and when considering group-level data, score below 47 was considered indicative of impaired functioning within that health domain or dimension. Positive value in change from Baseline indicated improvement.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16 for Placebo and BKZ
|
6.219 score on a scale
Standard Error 0.402
|
—
|
2.326 score on a scale
Standard Error 0.478
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: RS consisted of all enrolled participants who had been randomized. Participants who have missing MDA at Week 16 or who discontinued study treatment before Week 16 regardless of whether they have data or not are considered as non-responders. Inferential Statistics for ADA 40 mg reference arm was not calculated and reported as no formal comparison was planned.
MDA is measure to indicate disease remission, and is based on composite score of 7 domains. Participant is considered having achieved MDA if participant fulfills at least 5 of following 7 criteria: Tender joint count (0-68 joints) less than or equal to (≤1); Swollen joint count (0-66 joints) ≤ 1; PASI ≤ 1 or BSA ≤ 3: In PASI, body divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. Total score ranges from 0(no disease) to 72 (maximal disease)\]; Patient's Assessment of Arthritis Pain ≤ 15 \[using VAS on a scale of 0 (no pain) to 100 (severe pain)\]; Patient's Global Assessment of Disease Activity ≤ 20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤ 0.5, HAQ-DI score ranges from 0 (no difficulty) to 3 (maximum difficulty); Leeds Enthesitis Index score ≤ 1 for participants with enthesitis at baseline.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Minimal Disease Activity (MDA) at Week 16
|
45.0 percentage of participants
|
45.0 percentage of participants
|
13.2 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Radiographic Set (RAS): all participants in RS who received at least 1 dose of investigational medicinal product (IMP) and have valid radiographic image of hands and feet (with assessment performed by at least 2 reviewers) at Screening. Missing data and non-missing data preceded by treatment discontinuation were imputed using reference based multiple imputation. Here, number of participants analyzed included RAS with elevated hs-CRP and/or with at least one bone erosion at Baseline.
The degree of joint damage was assessed using the vdHmTSS by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively. The vdHmTSS ranges from 0 to 528, with higher scores representing greater damage. Descriptive statistics for ADA 40 mg reference arm was not calculated and reported since reference based imputation analysis method is used with Placebo as reference. As pre-specified in the SAP, this analysis was performed only for the participants randomized to Placebo and BKZ.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=361 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=227 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in Participants With Elevated Hs-CRP and/or at Least 1 Bone Erosion at Baseline at Week 16 for Placebo and BKZ
|
0.04 score on a scale
Standard Error 0.05
|
—
|
0.36 score on a scale
Standard Error 0.10
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16Population: As pre-specified in the SAP, the subgroup of participants with enthesitis at Baseline in the pooled population of PA0010 and PA0011 (NCT03896581) were included for the analysis of outcome measure. Participants who have missing LEI at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not are considered as non achieving entheistis free-state.
Presence of enthesitis was assessed in the subgroup of participants with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0 (no tenderness) and 1 (tenderness) at Baseline. The LEI consists of 6 items, 3 for the right part and 3 for the left part of the body. LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. Descriptive/Inferential statistics for ADA 40 mg reference arm was not calculated and reported since pooled data with PA0011 study is used which did not have ADA 40 mg arm.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=249 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=106 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an Enthesitis-free State in the Leeds Enthesitis Index (LEI) at Week 16 in the Subgroup of Participants With Enthesitis at Baseline in the Pooled Population of PA0010 and PA0011
|
49.8 percentage of participants
|
—
|
34.9 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16Population: As pre-specified in the SAP, the subgroup of participants with dactylitis at Baseline in the pooled population of PA0010 and PA0011 (NCT03896581) were included for the analysis of outcome measure. Participants who have missing LDI at Week 16 or who discontinued study treatment before Week 16 regardless of whether they have data or not are considered as non achieving dactylitis free-state.
The LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with a 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot). The ratio of circumference between an affected digit and the control digit is multiplied by the tenderness score for the affected digit. The results from each involved digit are summed to provide the final LDI score. A higher LDI indicates worse dactylitis. Tenderness score (0 = no tenderness, 1 = tender). Descriptive/Inferential statistics for ADA 40 mg reference arm was not calculated and reported since pooled data with PA0011 study was used which did not have ADA 40 mg arm.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=90 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=47 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Dactylitis-free State Based on the Leeds Dactylitis Index (LDI) at Week 16 in the Subgroup of Participants With Dactylitis at Baseline in the Pooled Population of PA0010 and PA0011
|
75.6 percentage of participants
|
—
|
51.1 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: RS consisted of all enrolled participants who had been randomized. Participants who have missing ACR20 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they have data or not are considered as non-responders.
The ACR20 response rate was based on a 20% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity (100 mm VAS \[0 = no symptoms; 100 = severe symptoms\]), Patient global assessment of disease activity (100 mm VAS \[0 = no limitation of normal activities; 100 = very poor\]), Patient assessment of pain (100 mm VAS \[0 = no pain; 100 = most severe pain\]), HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability, hsCRP.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16
|
62.2 percentage of participants
|
68.6 percentage of participants
|
23.8 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The RAS consisted of all participants in the randomized set who received at least 1 dose of IMP and have a valid radiographic image of the hands and feet (with an assessment performed by at least the 2 reviewers) at Screening. Missing data and non-missing data preceded by a study treatment discontinuation were imputed using reference based multiple imputation. As pre-specified in the SAP, this analysis was performed only for the participants randomized to Placebo and BKZ.
The degree of joint damage was assessed using the vdHmTSS by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively. The vdHmTSS ranges from 0 to 448, with higher scores representing greater damage. Descriptive statistics for ADA 40 mg reference arm was not calculated and reported since reference based imputation analysis method was used with Placebo as reference.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=420 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=269 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in the Overall Population at Week 16 for Placebo and BKZ
|
0.04 score on a scale
Standard Error 0.04
|
—
|
0.32 score on a scale
Standard Error 0.09
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: RS consisted of all enrolled participants who had been randomized. Participants who had missing ACR70 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not are considered as non-responders.
The ACR70 response rate was based on a 70% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity (100 mm VAS \[0 = no symptoms;100 = severe symptoms\]), Patient global assessment of disease activity (100 mm VAS \[0 = no limitation of normal activities;100 = very poor\]), Patient assessment of pain (100 mm VAS \[0 = no pain; 100 = most severe pain\]), HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability, hsCRP.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology (ACR) 70 Response at Week 16
|
24.4 percentage of participants
|
27.9 percentage of participants
|
4.3 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Subset of study participants in RS with psoriatic skin lesions at Baseline (minimal IGA score of 2) and with PSO involving at least 3% BSA at Baseline. Participants who had missing data at the Week 4 or who discontinued study treatment before or at the Week 4 regardless of whether they had data or not are considered as non-responders.
IGA measured the overall severity of PSO using the following 5-point scale and score was rated as 0 = clear (No signs of PSO; post-inflammatory hyperpigmentation may be present), 1 = almost clear (No thickening; normal to pink coloration; no to minimal focal scaling), 2 = mild (Just detectable to mild thickening; pink to light red coloration; predominately fine scaling), 3 = moderate (Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling), and 4 = severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response is defined as score of 0 (clear) or 1 (almost clear) with at least a 2-category improvement relative to Baseline.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=204 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=62 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=129 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) AND at Least a 2-grade Reduction From Baseline at Week 4 in the Subset of Participants With Psoriatic Skin Lesions at Baseline
|
28.9 percentage of participants
|
11.3 percentage of participants
|
3.9 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Subset of study participants in RS with psoriatic skin lesions at Baseline (minimal IGA score of 2) and with PSO involving at least 3% BSA at Baseline. Participants who had missing data at the Week 16 or who discontinued study treatment before or at the Week 16 regardless of whether they had data or not are considered as non-responders.
IGA measured the overall severity of PSO using the following 5-point scale and score was rated as 0 = clear (No signs of PSO; post-inflammatory hyperpigmentation may be present), 1 = almost clear (No thickening; normal to pink coloration; no to minimal focal scaling), 2 = mild (Just detectable to mild thickening; pink to light red coloration; predominately fine scaling), 3 = moderate (Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling), and 4 = severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response is defined as score of 0 (clear) or 1 (almost clear) with at least a 2-category improvement relative to Baseline.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=204 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=62 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=129 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an IGA Response Defined as Score of 0 (Clear) or 1 (Almost Clear) AND at Least a 2-grade Reduction From Baseline at Week 16 in the Subset of Participants With Psoriatic Skin Lesions at Baseline
|
50.5 percentage of participants
|
33.9 percentage of participants
|
3.9 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: RS consisted of all enrolled participants who had been randomized. Missing data and non-missing data preceded by a study treatment discontinuation were imputed using reference based multiple imputation.
The PtAAP VAS is part of the American College of Rheumatology core set of measures in arthritis. Participants assessed their arthritis pain using a VAS ranging from 0 (no pain) to 100 (most severe pain). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
|
-23.6 score on a scale
Standard Error 1.3
|
-25.7 score on a scale
Standard Error 2.5
|
-6.3 score on a scale
Standard Error 1.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Subset of study participants in RS with SPARCC \> 0 at Baseline. Participants who had missing SPARCC at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not are considered as not achieving enthesitis free-state.
Presence of enthesitis was assessed in the subgroup of participants with enthesitis at Baseline. The SPARCC index measures the severity of enthesitis through the assessment of 16 sites, 8 for the right part and 8 for the left part of the body: the greater trochanter (right/left), quadriceps tendon insertion into the patella (right/left), patellar ligament insertion into the patella and tibial tuberosity (right/left), achilles tendon insertion (right/left), plantar fascia insertion (right/left), medial and lateral epicondyles (right/left), and the supraspinatus insertion (right/left). Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an average range of 0 (no enthesitis) to 16 (severe enthesitis).
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=166 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=44 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=90 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an Enthesitis-free State Based on the Spondyloarthritis Research Consortium of Canada (SPARCC) Index at Week 16 in the Subgroup of Participants With Enthesitis at Baseline
|
50.0 percentage of participants
|
52.3 percentage of participants
|
35.6 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: RS consisted of all enrolled participants who had been randomized. Missing data and non-missing data preceded by a study treatment discontinuation were imputed using reference based multiple imputation.
The PsAID-12 is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each domain score was multiplied by a weighting factor and the results were then summed to provide the total score. The total score ranged from 0 to 10, with higher scores indicating a worse status. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16
|
-1.83 score on a scale
Standard Error 0.09
|
-2.14 score on a scale
Standard Error 0.16
|
-0.53 score on a scale
Standard Error 0.10
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline until Safety Follow-Up (up to Week 72)Population: The Safety Set consisted of all participants who received at least 1 dose of the IMP. The ATS consisted of all participants who received at least 1 dose of active treatment (BKZ or ADA) during the ATP (Week 16 and after).
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
n=271 Participants
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
n=414 Participants
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
n=136 Participants
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
|
59.6 percentage of participants
|
59.3 percentage of participants
|
49.5 percentage of participants
|
70.5 percentage of participants
|
72.0 percentage of participants
|
68.4 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline until Safety Follow-Up (up to Week 72)Population: The Safety Set consisted of all participants who received at least 1 dose of the IMP. The ATS consisted of all participants who received at least 1 dose of active treatment (BKZ or ADA) during the ATP (Week 16 and after).
A SAE is any untoward medical occurrence that at any dose: Results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization; is a congenital anomaly or birth defect; is an infection that requires treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
n=271 Participants
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
n=414 Participants
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
n=136 Participants
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
|
1.9 percentage of participants
|
1.4 percentage of participants
|
1.1 percentage of participants
|
5.9 percentage of participants
|
5.6 percentage of participants
|
6.6 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline until Safety Follow-Up (up to Week 72)Population: The Safety Set consisted of all participants who received at least 1 dose of the IMP. The ATS consisted of all participants who received at least 1 dose of active treatment (BKZ or ADA) during the ATP (Week 16 and after).
An AE is any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP.
Outcome measures
| Measure |
BKZ 160 mg Q4W
n=431 Participants
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 Participants
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo
n=281 Participants
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
Placebo/BKZ 160 mg Q4W
n=271 Participants
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
n=414 Participants
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
n=136 Participants
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With TEAEs Leading to Withdrawal From IMP During the Study
|
1.9 percentage of participants
|
2.1 percentage of participants
|
1.1 percentage of participants
|
1.8 percentage of participants
|
2.7 percentage of participants
|
3.7 percentage of participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
BKZ 160 mg Q4W
Serious events: 8 serious events
Other events: 77 other events
Deaths: 0 deaths
ADA 40 mg Q2W
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo/BKZ 160 mg Q4W
Serious events: 16 serious events
Other events: 54 other events
Deaths: 1 deaths
BKZ 160 mg Q4W/BKZ 160 mg Q4W
Serious events: 23 serious events
Other events: 82 other events
Deaths: 0 deaths
ADA 40 mg Q2W/ADA 40 mg Q2W
Serious events: 9 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=281 participants at risk
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
BKZ 160 mg Q4W
n=431 participants at risk
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 participants at risk
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo/BKZ 160 mg Q4W
n=271 participants at risk
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
n=414 participants at risk
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
n=136 participants at risk
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.23%
1/431 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.23%
1/431 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.23%
1/431 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.71%
1/140 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.23%
1/431 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.23%
1/431 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.23%
1/431 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.36%
1/281 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.23%
1/431 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.23%
1/431 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.23%
1/431 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.36%
1/281 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Enchondromatosis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.71%
1/140 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.23%
1/431 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.36%
1/281 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 2 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Endocrine disorders
Goitre
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.74%
1/136 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
General disorders
Chest pain
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.74%
1/136 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Gangrene
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Otitis media
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.74%
1/136 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.74%
1/136 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Upper respiratory tract infections
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Urinary tract infections
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Cystitis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.74%
1/136 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.74%
1/136 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.74%
1/136 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
1.5%
2/136 • Number of events 2 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.48%
2/414 • Number of events 2 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia stage 0
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 2 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Reproductive system and breast disorders
Uterine inflammation
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.74%
1/136 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 2 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Respiratory, thoracic and mediastinal disorders
Vascular disorders
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Respiratory, thoracic and mediastinal disorders
Deep vein thrombosis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.37%
1/271 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/414 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Respiratory, thoracic and mediastinal disorders
Hypertension
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/431 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/271 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.24%
1/414 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/136 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
Other adverse events
| Measure |
Placebo
n=281 participants at risk
Participants received placebo during the 16-weeks Double-Blind Treatment Period (DBP).
|
BKZ 160 mg Q4W
n=431 participants at risk
Participants received Bimekizumab (BKZ) 160 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) during the 16-weeks DBP.
|
ADA 40 mg Q2W
n=140 participants at risk
Participants received Adalimumab (ADA) 40 mg SC every 2 weeks (Q2W) during the 16-weeks DBP.
|
Placebo/BKZ 160 mg Q4W
n=271 participants at risk
After the 16-weeks DBP, participants initially randomized to placebo received BKZ 160 mg SC Q4W during the 36-weeks Active Treatment-Blind Period (ATP).
|
BKZ 160 mg Q4W/BKZ 160 mg Q4W
n=414 participants at risk
After the 16-weeks DBP, participants initially randomized to BKZ 160 mg continued to receive BKZ 160 mg SC Q4W during the 36-weeks ATP.
|
ADA 40 mg Q2W/ADA 40 mg Q2W
n=136 participants at risk
After the 16-weeks DBP, participants initially randomized to ADA 40 mg continued to receive ADA 40 mg SC Q2W during the 36-weeks ATP.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.6%
13/281 • Number of events 14 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
9.3%
40/431 • Number of events 44 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
5.0%
7/140 • Number of events 8 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
8.5%
23/271 • Number of events 28 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
7.0%
29/414 • Number of events 31 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
4.4%
6/136 • Number of events 7 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
18/281 • Number of events 18 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
5.1%
22/431 • Number of events 25 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
2.1%
3/140 • Number of events 3 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
4.4%
12/271 • Number of events 15 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
4.8%
20/414 • Number of events 21 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
3.7%
5/136 • Number of events 7 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/281 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
2.1%
9/431 • Number of events 10 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.00%
0/140 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
5.2%
14/271 • Number of events 14 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
4.6%
19/414 • Number of events 26 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
0.74%
1/136 • Number of events 1 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
4/281 • Number of events 5 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
2.1%
9/431 • Number of events 9 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
2.1%
3/140 • Number of events 3 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
5.5%
15/271 • Number of events 17 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
4.8%
20/414 • Number of events 20 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
2.2%
3/136 • Number of events 6 • From Baseline until Safety Follow-Up (up to Week 72)
TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. TEAEs were analyzed and reported for Double-Blind Treatment Period (safety set) and Active Treatment-Blind Period (ATS) separately.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60